survey of manufacturing practices in the dietary ... 17, 2000 survey of manufacturing practices in...

May 17, 2000

Survey of Manufacturing Practicesin the Dietary Supplement Industry

Final Report

Prepared for

Ed ArnoldU.S. Department of Health and Human Services

Food and Drug AdministrationOFACS/DCPM

Contracts Operation Branch, HFA-5125600 Fishers Lane, FHSL Bldg., Room 2117

Rockville, MD 20857

Prepared by

Sheryl C. CatesShawn A. Karns

Heather L. Carter-YoungPeter H. Siegel

Center for Economics ResearchResearch Triangle Institute

Research Triangle Park, NC 27709

RTI Project Number 6673-6

Center for Economics Research

RTI Project Number6673-6

Survey of Manufacturing Practicesin the Dietary Supplement Industry

Final Report

May 17, 2000

Prepared for

Ed ArnoldU.S. Department of Health and Human Services

Food and Drug AdministrationOFACS/DCPM

Contracts Operation Branch, HFA-5125600 Fishers Lane, FHSL Bldg., Room 2117

Rockville, MD 20857

Prepared by

Sheryl C. CatesShawn A. Karns

Heather L. Carter-YoungPeter H. Siegel

Center for Economics ResearchResearch Triangle Institute

Research Triangle Park, NC 27709

iii

Contents

1. Introduction 1-1

2. Sample Design 2-1

2.1 Survey Universe ................................................................ 2-1

2.2 Sample Stratification ......................................................... 2-1

2.2.1 Product Type Stratification..................................... 2-2

2.2.2 Size Stratification................................................... 2-2

2.3 Sample Allocation............................................................. 2-4

3. Survey Design and Administration 3-1

3.1 Survey Instrument Design.................................................. 3-1

3.2 Procedures........................................................................ 3-2

3.3 Survey Response ............................................................... 3-4

3.4 Updating the DS-EED........................................................ 3-9

4. Survey Results 4-1

4.1 Weighting Procedures ....................................................... 4-1

4.2 Analysis Procedures .......................................................... 4-2

4.3 Selected Results ................................................................ 4-4

References R-1

Appendixes

A Mail Survey.......................................................................A-1

B Lead Letter and Brochure .................................................. B-1

C Weighting Procedures .......................................................C-1

D Weighted Results by Establishment Size ............................D-1

E Weighted Results by Product Type .....................................E-1

iv

Figures

Figure 3-1 Telephone-Mail-Telephone Survey Approach............................. 3-3

v

Tables

Table 2-1 Survey Universe, by Sampling Strata .......................................... 2-4

Table 2-2 Initial Sample Sizes, by Sampling Strata ..................................... 2-5

Table 2-3 Final Sample Sizes, by Sampling Strata....................................... 2-7

Table 3-1 Number of Completed Interviews, by Sampling Strata ................ 3-4

Table 3-2 Final Disposition of Sample and Response Rates, by ProductType .......................................................................................... 3-5

Table 3-3 Final Disposition of Sample and Response Rates, byEstablishment Size ..................................................................... 3-6

Table 3-4 Records Deleted from the DS-EED ........................................... 3-10

Table 4-1 Number of Respondents by Reporting Domains ......................... 4-3

Table 4-2 Plant Characteristics .................................................................. 4-5

Table 4-3 Good Manufacturing Practices (GMPs)....................................... 4-8

Table 4-4 Personnel .................................................................................. 4-9

Table 4-5 Buildings and Facilities ............................................................ 4-10

Table 4-6 Equipment ............................................................................... 4-12

Table 4-7 Quality Control and Laboratory Operations.............................. 4-13

Table 4-8 Production and Process Controls.............................................. 4-15

Table 4-9 Warehousing ........................................................................... 4-16

Table 4-10 Consumer Complaints.............................................................. 4-17

1-1

1 Introduction

In November 1995, representatives of the dietary supplementindustry submitted to the Food and Drug Administration (FDA) asuggested outline for developing good manufacturing practice (GMP)regulations to ensure that dietary supplements are safe for consumersfor their intended use. Through regulation, the Secretary mayprescribe GMP regulations for dietary supplements. If suchregulations were to be prescribed, they would be modeled aftercurrent GMPs for food.

FDA contracted with the Research Triangle Institute (RTI) to conducta survey of the dietary supplement industry to learn about the existingmanufacturing practices in the industry and what constitutes GMPs.This effort is part of the process of considering whether to instituterule making to develop GMP regulations.

The objectives of the survey were to

Z learn about the existing manufacturing practices in theindustry and

Z help the agency formulate a policy to ensure that dietarysupplement products are produced under conditions thatwill result in a safe and properly labeled product withoutunnecessary costs to the industry.

We selected a sample of 966 dietary supplement establishmentsfrom the Dietary Supplement Enhanced Establishment Database(DS-EED) using a stratified systematic sample design. A telephone-mail-telephone survey approach was used for data collection. Weconducted telephone interviews to screen establishments foreligibility and to recruit eligible establishments for the mail survey.Nonrespondents to the mail survey were contacted by telephone to

Survey of Manufacturing Practices in the Dietary Supplement Industry

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remind them to complete and return the mail survey. We receiveda total of 238 completed surveys.

This report describes the sample design and survey administrationprocedures and presents summary statistics for the survey questions.The report is organized as follows: Section 2 describes the sampledesign, Section 3 discusses the survey instrument design and oursurvey administration procedures, and Section 4 describes ourweighting and analysis procedures and presents selected surveyresults.

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2 Sample Design

In this section, we present the sample design for the survey. Wedescribe the universe for the survey, the sample stratification, andthe sample allocation.

2.1 SURVEY UNIVERSEThe universe for this survey is defined as the 1,9731 dietarysupplement establishments in the DS-EED that manufacture,repackage, supply ingredients, distribute, import, or export dietarysupplement products. RTI developed the DS-EED using FDA’sOfficial Establishment Inventory (OEI) and supplemented theinformation in the OEI with information from trade organizations,trade shows, and electronic databases that cover various aspects ofthe industry (Muth and Wendling, 1999).

2.2 SAMPLE STRATIFICATIONThe primary purpose of stratification is to ensure that estimates forpopulation subdivisions are precise. In this case, subdivisions ofthe population of particular interest are product type andestablishment size because these characteristics will be importantfactors influencing the prevalence of GMP procedures.

1Version 1 of the DS-EED contained 2,004 records. Thirty-one duplicates were

found in the data cleaning process and were removed from the sampling frame,resulting in 1,973 records.


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The DS-EED includes nine product type codes: vitamins andminerals,2 herbals and botanicals, herbal and botanical extracts,amino acids, proteins, animal extracts, tea-like products,concentrates/metabolites/constituents, and other dietarysupplements. Establishments may be classified by one or moreproduct type. For stratification and reporting results, we definedfour mutually exclusive superstrata:

1. Vitamins and minerals (includes establishments alsoclassified as herbals and botanicals or aminoacids/proteins/animal extracts)

2. Amino acids/proteins/animal extracts (includesestablishments also classified as herbals and botanicals;excludes establishments also classified as vitamins andminerals)

3. Herbals and botanicals, including extracts (excludesestablishments also classified as vitamins and minerals oramino acids/proteins/animal extracts)

4. Other dietary supplements (all other product types)

We further stratified each of the four superstrata into four sizecategories—very small, small, large, and unknown—resulting in 16sampling strata.

We also classified each establishment into one mutually exclusivefacility type category (manufacturer, input supplier,repacker/relabeler, distributor, other). Establishments thatmanufacture and are also input suppliers, repackers, or distributorsare classified as manufacturers.

2.2.1 Product Type Stratification

Using the product type codes in the DS-EED, we classified eachestablishment into one of the four superstrata: (1) vitamins andminerals, (2) amino acids/proteins/animal extracts, (3) herbals andbotanicals, and (4) other dietary supplements.

2.2.2 Size Stratification

The Small Business Administration (SBA) classifies companies assmall based on the size of the entire company or firm. Because theDS-EED data on size are only for a specific establishment, we hadto obtain parent company information on employment and/or 2Vitamins and minerals are grouped together because most plants that manufacture

either of these also manufacture the other.

Section 2 — Sample Design

2-3

revenue to correctly classify each establishment as part of a smallor large company. To obtain parent company data forestablishments in the survey universe, we sent infoUSA the DS-EEDdata records (N=2,004) and requested (among other variables) thename, address, primary SIC code, employment size (in ranges), andrevenue (in ranges) of parent company firms with establishments inthe survey universe. InfoUSA matched 1,219 of the 2,004 recordsin the DS-EED to their U.S. database of 10.3 million businesses.

Of the 1,219 matched records, 31 records were found to beduplicates of other records and were removed, giving a total of1,188 matched records and 1,973 total records in the samplingframe. The non-matched records (785 establishments) did notmatch because they are recently established businesses, they areout of business, or because there has been a name or addresschange. Because data on employment or revenue size were notavailable for the non-matched records, we created an “unknown”size stratum for these establishments. In reporting results, we usedthe survey responses on number of employees to correctly classifythese establishments.

Of the 1,188 matched records, 180 were linked to ultimate parents.The parent company data for these 180 establishments weremerged with the survey universe. The remaining 1,008 records didnot link to an ultimate parent company. For these records, theestablishment and parent company were the same entity, so weused establishment-level data to define the establishment’s size.

Using SBA size standards, each of the 1,973 establishments in thesurvey universe was classified as part of a small or large businessbased on the employment size or annual revenues of eachestablishment’s parent company. The SBA size standards representthe largest size a firm may be, in terms of either the number ofemployees or annual receipts, and still remain eligible as a smallbusiness for various types of federal assistance. When anestablishment did not have a parent company (i.e., when a matchedrecord in the DS-EED survey universe did not link with an ultimateparent in the infoUSA database), the employment size or annualrevenues of the establishment were used to categorize theestablishment. If an establishment’s parent company had 500 orfewer employees or sales less than $20 million (if data on


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employment were not available), then the establishment wasclassified as small.

Because the dietary supplement industry is characterized by smallestablishments, we further divided small establishments into twocategories based on employment size—very small and small. Anestablishment was classified as very small if the number ofemployees is less than 20. Table 2-1 shows the number ofestablishments in the survey universe or population by the 16sampling strata.

Table 2-1. Survey Universe, by Sampling Strata

Very Small Small Large Unknown

NumberPercent

(%) NumberPercent

(%) NumberPercent

(%) NumberPercent

(%) Total

1. Vitamins and Minerals 317 29.8 281 26.5 98 9.2 366 34.5 1,062

2. Amino Acids/Proteins/Animal Extracts

27 31.0 20 23.0 6 6.9 34 39.1 87

3. Herbals and Botanicals 187 42.6 58 13.2 5 1.1 189 43.1 439

4. Other 117 30.4 83 21.6 25 6.5 160 41.6 385

Total 648 32.8 442 22.4 134 6.8 749 38.0 1,973

Note: 1: Vitamins and minerals—includes establishments also classified as herbals and botanicals or aminoacids/proteins/animal extracts.

2: Amino acids/proteins/animal extracts—includes establishments also classified as herbals and botanicals;excludes establishments also classified as vitamins and minerals.

3: Herbals and botanicals, including extracts—excludes establishments also classified as vitamins and mineralsor amino acids/proteins/animal extracts.

4: Other—all other product types.aTotals may not add to 100 percent due to rounding.

2.3 SAMPLE ALLOCATIONOur sample allocation approach was designed to produce valid andreliable results that can be generalized to the subpopulations ofinterest—product type and establishment size. The sampleallocation used was designed to yield 400 completed surveys.Table 2-2 presents the sample allocation for the initial sample sizeof 941 establishments.


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Table 2-2. Initial Sample Sizes, by Sampling Strata

Size

Product Type Very Small Small Large Unknown Total

1. Vitamins and Minerals

Initial Sample Size 68 105 59 34 266

Expected Number of Respondents 28 43 34 14 119

2. Amino Acids/Proteins/Animal Extracts



3. Herbals and Botanicals



4. Other



Total



The initial sample sizes were based on the following assumptions:

Z The contact rate (reachable phone number) will be at least83 percent for the very small, small, and unknown sizestrata and 95 percent for the large stratum (overall contactrate of 85 percent).

Z The eligibility rate (dietary supplement establishment) willbe at least 90 percent for all strata.

Z The recruiting rate for the initial telephone interview (Part 1)will be at least 74 percent for the very small, small, andunknown size strata and 82 percent for the large stratum(overall Part 1 response rate of 75 percent).

Z The response rate for the mail survey (Part 2) will be at least74 percent for the very small, small, and unknown sizestrata and 82 percent for the large stratum (overall Part 2response rate of 75 percent).

To achieve the desired number of completes by strata, weoversampled some strata, undersampled some strata, and took a


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census (i.e., selected all sample points) for some strata. If we took aproportionate sample, then all strata would have a sampling rate ofapproximately 941/1,973=48 percent (sample size/population).When we do not take a census but the sampling rate is greater than48 percent, then it is an oversample; likewise, if the sampling rate isless than 48 percent, then it is an undersample.

We allocated the sample across the 16 product type and size strataas follows:

Z For the vitamins and minerals product type, weundersampled the very small, small, and unknown sizestrata and oversampled the large size stratum.

Z For the amino acids/proteins/animal extracts product type,we selected all sample points (i.e., took a census) in each ofthe four size stratum.

Z For the herbals and botanicals product type, we took acensus of the very small, small, and large size strata andoversampled the unknowns.

Z For the “other” product type, we took a census of the largesize stratum, oversampled the very small and small sizestrata, and undersampled the unknowns.

Prior to selecting the sample, we sorted by facility type within eachof the 16 sampling stratum. Then we selected a stratifiedsystematic sample so that the facility types were proportionallyrepresented in each product type/size stratum.

Because the actual eligibility rates were lower than anticipated, wedrew additional sample for the herbals and botanicals/unknownstratum, which resulted in taking a census of this stratum. Timeconstraints prevented us from drawing additional sample from theother strata. The final sample size was 966 establishments.Table 2-3 shows the final sample sizes, by the 16 sampling strata.


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Table 2-3. Final Sample Sizes, by Sampling Strata

Size


1. Vitamins and Minerals 68 105 59 34 266

2. Amino Acids/Proteins/Animal Extracts 27 20 6 34 87

3. Herbals and Botanicals 187 58 5 189 439

4. Other 64 61 25 24 174

Total 346 244 95 281 966

3-1

Survey Design and3 Administration

In this section, we describe the design of the mail survey instrumentand our survey administration procedures, and present the surveyresponse rates. We also discuss how we used the survey results toupdate the DS-EED.

3.1 SURVEY INSTRUMENT DESIGNA telephone-mail-telephone survey approach was used for datacollection. We initially contacted establishments in the sample bytelephone and screened them for eligibility. Eligible respondentswere recruited for the mail survey. For nonrespondents to the mailsurvey, we made follow-up telephone calls to remind them tocomplete and return the mail survey. Appendix A provides a copyof the final mail survey instrument.

The survey was designed to determine the extent to whichestablishments use written procedures and maintain records forspecific manufacturing practices. We developed the survey basedon the current GMPs for food (21 CFR Part 110), the AdvanceNotice of Proposed Rulemaking for Current GMPs inManufacturing, Packing, or Holding Dietary Supplements (vol. 62,no. 25, February 6, 1997), and input from FDA staff.

The survey is organized as follows:

1. Products and Markets

2. Good Manufacturing Practices (GMPs)

3. Personnel

4. Buildings and Facilities


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5. Equipment

6. Quality Control and Laboratory Operations

7. Production and Process Controls

8. Warehousing

9. Consumer Complaints

10. Plant Information

To pretest the survey instrument, we conducted telephoneinterviews with four dietary supplement establishments. FDA hadpreviously visited these establishments as part of this project. Wesent the survey to the selected establishments and asked them tocomplete the survey; then we conducted a telephone interview toobtain their feedback on the survey instrument. Based on thecomments provided by the pretest respondents, we revised thesurvey instrument. Because we made only minor revisions to thesurvey instrument, we were able to include the pretest responses inthe full-scale analysis.

The Information Collection Request Supporting Statement wassubmitted to the Office of Management and Budget (OMB) onSeptember 29, 1999. The information collection request receivedemergency processing. OMB approval was received onNovember 22, 1999.

3.2 PROCEDURESFigure 3-1 illustrates our survey approach. First, we sent eachestablishment in the sample a lead letter on FDA letterhead and a1-page brochure to explain the purpose of the survey, the value ofthe establishments’ participation, and our confidentialityprocedures. Appendix B provides a copy of the lead letter andbrochure.

We followed this mailing with a telephone call to eachestablishment to screen them for eligibility and to recruit eligibleestablishments for the mail survey. To be eligible for the survey,establishments had to currently manufacture, repackage, supplyingredients, distribute, import, or export dietary supplementproducts for human consumption. Establishments that were brokersonly or were a headquarters site with no manufacturing operationswere not eligible. We found that about 50 percent of theestablishments sampled were not eligible for the survey because

Section 3 — Survey Design and Administration

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Figure 3-1. Telephone-Mail-Telephone Survey Approach

InitialTelephoneInterview

� Screen foreligibility

� Recruit for mailsurvey

SendLead Letter

on FDALetterhead

Mail SurveyMaterials

toRecruits

ElectronicDatabase ofResponses

ConductTelephone

Follow-Ups withNonrespondents

Part 1 Part 2—Mail/TelephoneFollow-up

they were no longer in operation or did not have any dietarysupplement operations (e.g., made dietary supplements for pets,herbs/spices used for food, homeopathic remedies, or herbal beautyproducts).

We sent recruited establishments the survey via Federal Express toexpedite the delivery and to signify the importance of the survey.The mailing included a postage-paid envelope for returning themail survey.

We conducted follow-up telephone calls with nonrespondents tothe mail survey to remind them to complete and return the survey;if such attempts were unsuccessful, on the third callback weattempted to complete the interview over the telephone. We foundthat most establishments were not willing to complete the surveyover the telephone.

We used a variety of procedures to maximize our response rate. Aspreviously mentioned, we sent prospective respondents a lead letteron FDA letterhead and a 1-page brochure describing the researchstudy (see Appendix B). This letter included a contact name andphone number at FDA and assured respondents that all resultswould be kept confidential. Also, the letter offered to sendrespondents an aggregated summary of the survey results as anincentive to participate.

We also operated a toll-free survey help line during the full-scalesurvey administration. Respondents could call the survey help lineto request assistance when completing the mail survey.


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For the initial and follow-up telephone interviews, we attempted tocontact each sample point (i.e., talk with an employee at theestablishment) up to 8 times before assigning a disposition ofnonresponse. For nonrespondents to the initial and follow-uptelephone interviews, we attempted up to two refusal conversions.Finally, as previously mentioned, we used Federal Express to mailthe survey materials.

Our subcontractor, Harris Interactive, administered the survey usingcomputer-assisted telephone interviewing (CATI). We conductedthe full-scale data collection over a 10-week period fromNovember 29, 1999 to February 4, 2000. Limited telephoneinterviewing took place between Christmas and New Years Day.

3.3 SURVEY RESPONSEWe received a total of 238 completed mail surveys. Table 3-1shows the number of completed surveys by sampling strata.

Table 3-1. Number of Completed Surveys, by Sampling Strata

Size


1. Vitamins and Minerals 19 39 13 1a 72

2. Amino Acids/Proteins/Animal Extracts 8 7 0 5 20

3. Herbals and Botanicals 58 25 0 30 113

4. Other 14 13 2 4 33

Total 99 84 15 40 238

aFor weighting purposes, we moved this respondent to the small stratum. See Appendix C for a description of theweighting procedures.

Tables 3-2 and 3-3 present the final disposition of the sample andthe response rates by product type and size, respectively. Wepresent this information separately for the initial telephoneinterview and the mail survey. For the initial telephone interview(Part 1), we assigned each sample point a disposition of recruit,refusal, or ineligible. In the following cases, eligibility status couldnot be determined:


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Table 3-2. Final Disposition of Sample and Response Rates, by Product Type

Vitaminsand

Minerals

Amino Acids/Proteins/

Animal ExtractsHerbals andBotanicals Other Total

Initial Telephone Interview(Part 1)

Recruits 132 39 219 54 444

Refusals 33 9 32 9 83

Ineligibles 101 39 188 111 439

Total Sample 266 87 439 174 966

Eligibility Rate (%) 62.03 55.17 57.18 36.21 54.55

Recruiting Response Rate (%) 80.00 81.25 87.25 85.71 84.25

Mail Survey (Part 2)

Respondents 72 20 113 33 238

Nonrespondents 51 17 80 15 163

Ineligibles 9 2 26 6 43

Total Recruits 132 39 219 54 444


Mail Survey Response Rate (%) 58.54 54.05 58.55 68.75 59.35

Overall Eligibility Rate (%) 58.65 52.87 51.25 32.76 50.10

Overall Response Rate (%) 46.83 43.92 51.08 58.93 50.00

Z The sample point was contacted but did not complete thescreening questions (e.g., the individual identified as thecontact person was not available or asked to be calledback).

Z The sample point was contacted but refused to participateprior to answering the screening questions.

Z The sample point was contacted but there was a languagebarrier.

For sample points where the eligibility status was unknown, weestimated the proportion of eligibles among known eligibles andineligibles and used this proportion to distribute the unknownsbetween eligibles (i.e., refusals) and ineligibles.


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Table 3-3. Final Disposition of Sample and Response Rates, by Establishment Size

Very Small Small Large Unknown Total

Initial Telephone Interview(Part 1)

Recruits 186 133 33 92 444

Refusals 33 26 7 17 83

Ineligibles 127 85 55 172 439

Total Sample 346 244 95 281 966


Recruiting Response Rate (%) 84.93 83.65 82.50 84.40 84.25

Mail Survey (Part 2)

Respondents 99 84 15 40 238

Nonrespondents 74 40 13 36 163

Ineligibles 13 9 5 16 43

Total Recruits 186 133 33 92 444


Mail Survey Response Rate (%) 57.23 67.74 53.57 52.63 59.35

Overall Eligibility Rate (%) 59.54 61.48 36.84 33.10 50.10

Overall Response Rate (%) 48.60 56.66 44.20 44.42 50.00

The “ineligibles” disposition includes the following:

Z sample points that do not currently manufacture, repackage,supply ingredients, distribute, import, or export dietarysupplement products for human consumption;

Z sample points for which the telephone number wasdisconnected;

Z sample points that are out of business; and

Z a percentage of the sample points for which the eligibilitystatus was unknown.

Recruits are those sample points that completed the initialtelephone interview and agreed to be sent the mail survey. Refusalsare those sample points that were eligible for the survey butdeclined to participate (includes a percentage of the sample pointsthat refused to participate and the eligibility status was unknown).


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The eligibility rate for the initial telephone interview—theproportion of the total sample that was eligible for the survey—iscalculated as follows:

Eligibility Rate = RecruitsPart 1 + RefusalsPart 1

Total Sample (3.1)

The eligibility rate for all establishments sampled was 55 percent.This means that 55 percent, or 527 of the 966 sample points, metthe eligibility criteria for participating in the survey. The majority ofineligibles were sample points that had no dietary supplementoperations or had disconnected phone numbers.

The recruiting response rate for the initial telephone interview—theproportion of the total number of eligible sample points that agreedto be sent a mail survey—is calculated as follows:

Recruiting Response Rate = RecruitsPart 1

RecruitsPart 1 + RefusalsPart 1 (3.2)

The recruiting response rate for all establishments was 84 percent.The recruiting response rate did not vary much by size ofestablishment. Among the product type categories, the recruitingresponse rate was highest for the herbals and botanicals and theother product type category.

For the mail survey (Part 2), we assigned each sample pointrecruited for the mail survey a disposition of respondent,nonrespondent, or ineligible. Respondents are sample points thatcompleted the mail survey. Nonrespondents are sample points thatwere recruited for the mail survey but did not complete it.Ineligibles are sample points that were recruited for the mail surveybut were determined to be ineligible once they received the mailsurvey.

Since we found that some recruits were actually ineligible duringthe mail survey phase, we cannot assume that all nonrespondentsto the mail survey are eligible. We prorated the nonrespondentsbetween eligible nonrespondents and ineligibles using theproportion of eligibles among known eligibles and ineligibles forPart 2. The eligibility rate for Part 2 was calculated as shown inEquation 3.1. The Part 2 eligibility rate for all establishments was90 percent.


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The survey response rate for the mail survey—the proportion of therecruits that actually completed the mail survey—is calculated asfollows:

Mail SurveyResponse Rate =

RespondentsPart 2RespondentsPart 2 + NonrespondentsPart 2

(3.3)

The mail survey response rate for all establishments was59 percent. The mail survey response rate was highest for the smallsize category and the herbals and botanicals and vitamins andminerals product type categories.

The overall eligibility rate for Parts 1 and 2 is calculated as follows:

RecruitsPart 1 + RefusalsPart 1 – IneligiblesPart 2Total Sample (3.4)

The overall eligibility rate for all establishments was 50 percent.The eligibility rate was lowest among establishments in the largeand unknown size categories and the other product type category.

The overall response rate for Parts 1 and 2 is calculated as follows:

Overall Response Rate =

RecruitingResponse RatePart 1

• Mail Survey

Response RatePart 2(3.5)

The overall response rate for all establishments was 50 percent.Among the product type categories, the overall response rateranged from a low of 44 percent for amino acids/proteins/animalextracts to a high of 59 percent for the other category. Among thesize categories, the overall response rate ranged from a low of44 percent for the large and unknowns to a high of 57 percent forsmall establishments.

The shortfall in the number of respondents was caused by acombination of lower-than-expected eligibility rates and responserates for the mail survey.

Our estimated contact/eligibility rate was 76.5 percent. Our actualoverall eligibility rates were much lower—33 to 61 percent for verysmall, small, and unknown establishments and 37 percent for largeestablishments. Many of the establishments in the DS-EED are nolonger in business or do not have dietary supplement operations.

Our estimated recruiting rates for the initial telephone interviewwere 74 percent for very small, small, and unknown establishments


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and 82 percent for large establishments. Our actual recruiting rateswere higher—84 to 85 percent for very small, small, and unknownestablishments and 83 percent for large establishments. However,many of the establishments recruited for the mail survey did notcomplete and return the survey.

Our estimated response rates for the mail survey were 74 percentfor very small, small, and unknown establishments and 82 percentfor large establishments. Our actual response rates were muchlower—53 to 68 percent for very small, small, and unknownestablishments and 54 percent for large establishments.

The poor response rates for the mail survey result from thefollowing factors:

Z The most common reason given for not participating wasthe amount of time required to complete the survey,particularly the need to refer to records to complete some ofthe questions.

Z Concerns about confidentiality and a general mistrust ofFDA kept some plants from responding.

Z For some plants, concerns about legality issues keptcompanies from responding to the survey.

Z Data collection took place during the month of December,a difficult time for conducting surveys.

Z The data collection period was shorter (10 weeks) thangenerally recommended for a mail survey due to FDA’sreporting deadline. This prevented us from releasingadditional sample and making extensive follow-ups tononrespondents.

3.4 UPDATING THE DS-EEDWe used the data from the survey to update the DS-EED. Wedeleted records that were found to be ineligible for the survey andupdated location information.

Table 3-4 shows the types and number of plant or establishmentrecords deleted from the DS-EED. We deleted a total of 438 plantrecords. Version 1 of the DS-EED (used to draw the survey sample)contained 2,004 records (Muth and Wendling, 1999). Version 2 ofthe DS-EED contains 1,566 plant records (Muth, Karns, and Cates,2000). The number of establishments in the DS-EED, Version 2(1,566 establishments) is different from the estimated eligiblepopulation of 906 establishments (see Appendix C for a


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Table 3-4. Records Deleted from the DS-EED

Number of Records

DS-EED, Version 1 2,004

Records deleted

Duplicates 52a

No dietary supplement operations 234

Nonworking phone number 130

Out of business 22

Total 438

DS-EED, Version 2 1,566

aIn preparing the DS-EED for drawing the sample, we found 31 duplicates. We found 21 additional duplicates when weprepared Version 2, for a total of 52 duplicates. Records were considered duplicate entries when their informationmatched in all the following fields: address, city, state, and phone.

discussion of how we estimated the eligible population). Althoughwe can estimate the number of ineligible establishments using theweighted survey data, we can only delete records for ineligibleestablishments that we actually contacted during surveyadministration. The difference in the number of records in Version2 of the DS-EED and the estimated eligible population has noimpact on the survey results.

We also used the survey data to update the plant name, phonenumber, and location information when this information wasavailable. Updated information was available for 271 records.

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4 Survey Results

In this section, we briefly discuss our weighting and analysisprocedures and present selected survey results.

4.1 WEIGHTING PROCEDURESWe generated survey estimates by applying survey weights to therespondent record data. A brief summary of our weightingprocedures is provided below. Appendix C describes our weightingprocedures in greater detail.

Survey weights were computed in several steps:

1. Initial sampling weights were computed to reflect thedifferent probabilities of selection induced by the samplingdesign (i.e., by using different sampling rates in the variousstrata).

2. We then used weighting classes to adjust these weights fornonresponse to the initial telephone interview.

3. Because our population included Canadian establishmentsthat were not eligible for the survey, we post-stratified toadjust to the population size excluding Canadianestablishments.

4. We made a second nonresponse adjustment fornonresponse to the mail survey.

Nonresponse adjustments ensure that, within each weighting class,respondent weights sum to the population counts of eligibleestablishments. These adjustments, implemented with thecomputation and application of adjustment factors in each class,also tend to reduce the biases of nonresponse to the extent thatweighting classes are homogeneous.


4-2

4.2 ANALYSIS PROCEDURESAs discussed in Section 2, for stratification purposes we usedinformation in the DS-EED to classify establishments by producttype and size. To report the survey results, we classifiedrespondents by product type and by establishment size based ontheir answers to the survey. We defined the product type categoriesusing the responses to Question 1.2 (primary product type) andQuestion 1.3 (all other product types). Using the responses to thesetwo questions, we defined four mutually exclusive categories:

1. Vitamins and minerals (includes establishments alsoclassified as herbals and botanicals or aminoacids/proteins/animal extracts)

2. Amino acids/proteins/animal extracts (includesestablishments also classified as herbals and botanicals;excludes establishments also classified as vitamins andminerals)

3. Herbals and botanicals, including extracts (excludesestablishments also classified as vitamins and minerals oramino acids/proteins/animal extracts)

4. Other dietary supplements (all other product types)

Using the responses to the question in the initial telephoneinterview on total number of employees for the company that ownsthe plant, we classified respondents into one of three sizecategories:

1. Very small (less than 20 employees)

2. Small (20 to 500 employees)

3. Large (more than 500 employees)

Table 4-1 provides the number of respondents by the product typeand establishment size reporting domains. The number ofrespondents for the amino acids/proteins/animal extracts and otherproduct type category and the large size category is small formaking inferences to the population. This can be seen by the largeconfidence intervals associated with these analysis domains.

Some respondents (about 10 percent) found that some sections ofthe survey were not applicable. This was particularly true forestablishments that import or export only, or distribute only. Insome cases, these respondents would skip entire sections or onlyanswer a few questions in the section. A survey was not consideredcomplete if the respondent only completed sections 1, 2, and 10.

Section 4 — Survey Results

4-3

Number of Respondents

Product Type

Vitamins and Minerals 118

Amino Acids/Proteins/Animal Extracts 16

Herbals and Botanicals 97

Other 7

Total 238

Establishment Size

Very Small 110

Small 114

Large 14

Total 238

For survey sections 3, 4, 5, 8, and 9, we excluded from our analysisrespondents that did not answer any questions in that section. InAppendices D and E, a x.0 question is included at the beginning ofthe table (with the exception of Section 9) in which to report thepercentage of respondents that did not complete any questions inthat section. The x.0 questions were not included in the mailsurvey but are added for reporting purposes. For example, inTable D-3, we report that 9.10 percent of respondents answeredQuestion 3.0 as no. This means that 9.10 percent of respondentsdid not complete this section of the survey (i.e., no personnel atthat site handle raw materials, in-process materials, or finishedproduct).

Most statistical software packages assume simple random samplingfrom an infinite population and are not appropriate for varianceestimation of sample survey estimates. That is, they do notcompensate for survey design features such as stratification.Therefore, they would produce biased variance estimates for thesurvey data. We used Stata,3 a statistical analysis software tool, tocompute the weighted proportions and means and the 95 percent

3StataCorp. 1999. Stata Statistical Software: Release 6.0. College Station, TX:

Stata Corporation.

Table 4-1. Number ofRespondents byReporting Domains


4-4

confidence intervals for the point estimates. Stata takes intoaccount the stratified sample design when computing the variances.

For some analyses, we only had one respondent or observation in acell or strata and therefore could not compute variances. Forvariance estimation, we collapsed some strata so that for mostanalyses we had at least two observations per stratum and couldcompute variances.

4.3 SELECTED RESULTSTables 4-2 through 4-10 present summary statistics for selectedquestions by establishment size. Appendix D provides theweighted responses for all survey questions by establishment size,and Appendix E provides the weighted responses by product type.

In addition to the estimated proportions and means, we provide the95 percent confidence intervals for the point estimates. Theconfidence interval is the range of the estimate. For example, inTable 4-3 we report that the 95 percent confidence interval for thepercentage of dietary supplement establishments that have standardoperating procedures (SOPs) is between 71.54 and 86.02 percent.This means that we are 95 percent confident that the percentage ofdietary supplement establishments that have SOPs is between 71.54and 86.02 percent.


4-5

Ta

ble

4-2

. P

lan

t C

ha

rac

teri

stic

s

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

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rall

(n =

238

)

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CI

95%

CI

95%

CI

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igh

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igh

Type

of o

pera

tions

a

Man

ufac

ture

r62

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66.6

275

68.5

156

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78.3

99

62.5

934

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caps

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415

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trib

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969

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ary

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bals

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ract

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110

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62

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3150

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Her

bals

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anic

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238

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mal

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tiple

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tinue

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4-6

Ta

ble

4-2

. P

lan

t C

ha

rac

teri

stic

s (c

on

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ue

d)

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y Sm

all (

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)

95%

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4-7

Ta

ble

4-2

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pond

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cou

ld s

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t mor

e th

an o

ne r

espo

nse.

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pri

mar

y lin

e of

bus

ines

s is

the

line

of b

usin

ess

that

con

trib

utes

to th

e m

ajor

ity o

f rev

enue

s—ei

ther

gre

ater

than

50

perc

ent o

f rev

enue

s or

the

grea

test

of s

ever

allin

es s

uch

as 3

5 pe

rcen

t if a

ll ot

her

lines

con

trib

ute

less

.c E

stim

ated

con

fiden

ce in

terv

al fo

r lo

wer

bou

nd w

as le

ss th

an z

ero

so w

e tr

unca

ted

the

inte

rval

.


4-8

Ta

ble

4-3

. G

oo

d M

an

ufa

ctu

rin

g P

rac

tic

es

(GM

Ps)

Ver

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all (

n =

110

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(n =

14)

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(n =

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)

95%

CI

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n%

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n%

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w a

pub

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51.7

638

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65.0

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82.5

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88.9

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964

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For

plan

ts fo

llow

ing

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the

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odel

use

da

FDA

Foo

d G

MPs

4168

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49.6

582

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5263

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ance

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ice

ofPr

opos

ed R

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akin

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1

Nat

iona

l Nut

ritio

nal

Food

s A

ssoc

iatio

n(N

NFA

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Ps

1327

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2530

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343

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571.

1443

.12

3927

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FDA

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g C

GM

Ps10

16.6

66.

7235

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2933

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22.1

847

.26

973

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4830

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U.S

. Pha

rmac

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aG

MPs

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.56

6.64

35.6

525

36.7

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50.3

77

56.7

128

.31

81.2

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31.1

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.39

41.5

0

For

plan

ts n

ot fo

llow

ing

GM

Ps, h

ow p

lant

s ve

rify

iden

tity,

pur

ity, a

ndco

mpo

sitio

n of

ingr

edie

nts

and

prod

ucts

a

Sani

tatio

n st

anda

rdop

erat

ing

proc

edur

es(S

SOPs

)

822

.56

——

b6

14.1

8—

—b

00.

00—

—b

1419

.09

——

b

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er Q

A p

rogr

am11

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933

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——

b0

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——

b20

25.2

9—

—b

Cer

tific

ate

of A

naly

sis

2764

.55

——

b19

85.7

3—

—b

00.

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—b

4672

.02

——

b

Cer

tific

ate

of Id

entit

y10

11.9

6—

—b

623

.66

——

b0

0.00

——

b16

16.3

4—

—b

Oth

er17

45.5

7—

—b

724

.70

——

b0

0.00

——

b24

37.0

5—

—b

Hav

e st

anda

rd o

pera

ting

proc

edur

es (S

OPs

)79

65.1

750

.98

77.1

010

491

.11

81.0

896

.08

1288

.98

63.9

797

.35

195

79.7

371

.54

86.0

2

a Res

pond

ents

cou

ld s

elec

t mor

e th

an o

ne r

espo

nse.

b Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.


4-9

Ta

ble

4-4

. P

ers

on

ne

l

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

Hav

e w

ritte

n pr

oced

ures

on d

isea

se c

ontr

ol47

55.7

441

.51

69.0

974

71.1

758

.99

80.9

013

100.

0010

0.00

100.

0013

466

.62

57.9

674

.29

Hav

e w

ritte

n pr

oced

ures

on m

aint

aini

ng p

erso

nal

clea

nlin

ess

6769

.80

55.0

181

.38

9584

.99

72.3

992

.44

1310

0.00

100.

0010

0.00

175

79.7

871

.44

86.1

6

Hav

e w

ritte

n pr

oced

ures

on e

duca

tion,

trai

ning

,or

exp

erie

nce

requ

irem

ents

5353

.95

39.4

167

.84

8270

.98

58.2

081

.12

1293

.15

63.8

499

.06

147

65.4

356

.37

73.4

9

Mai

ntai

n re

cord

s of

pers

onne

l edu

catio

n,tr

aini

ng, o

r ex

peri

ence

5454

.22

39.6

368

.12

8473

.66

61.3

183

.15

1293

.15

63.8

499

.06

150

67.0

057

.99

74.9

2


4-10

Ta

ble

4-5

. B

uild

ing

s a

nd

Fa

cilit

ies

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

Faci

lity

Ow

ners

hipa

Ow

ned

3936

.10

24.0

150

.27

6859

.80

47.4

771

.00

1185

.17

55.4

196

.37

118

51.1

942

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59.8

8

Leas

ed62

63.9

049

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75.9

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029

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52.5

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14.8

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6344

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107

48.8

140

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57.5

7

Ow

ned

Faci

litie

s

Hav

e w

ritte

n pr

oced

ures

on m

aint

enan

ce o

f the

grou

nds

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t the

pla

nt

924

.33

9.49

49.6

338

60.3

545

.34

73.6

410

90.6

353

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98.7

757

52.3

540

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63.7

9

Hav

e w

ritte

n pr

oced

ures

on g

ener

al m

aint

enan

cean

d sa

nita

tion

of th

ebu

ildin

gs, f

ixtu

res,

and

othe

r ph

ysic

al fa

cilit

ies

of th

e pl

ant

2061

.22

41.9

577

.52

5479

.35

63.6

689

.39

1094

.46

68.4

899

.26

8475

.31

64.7

483

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Hav

e w

ritte

n pr

oced

ures

on th

e st

orag

e an

d us

e of

clea

ning

and

san

itizi

ngm

ater

ials

1652

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31.3

173

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4769

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881

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1110

0.00

100.

0010

0.00

7467

.13

55.1

777

.22

Hav

e w

ritte

n pr

oced

ures

on p

est c

ontr

ol20

59.4

037

.16

78.3

652

77.2

761

.84

87.6

910

94.4

668

.48

99.2

682

73.4

862

.04

82.4

5

(con

tinue

d)


4-11

Ta

ble

4-5

. B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

Leas

ed F

acili

ties

Hav

e w

ritte

npr

oced

ures

on

mai

nten

ance

of t

hegr

ound

s ab

out t

he p

lant

or v

erify

and

kee

pre

cord

s th

at fa

cilit

yow

ner

is ta

king

pro

per

mea

sure

s

1019

.79

8.65

39.1

318

32.9

817

.93

52.5

61

46.1

84.

9393

.42

2925

.95

16.1

139

.00

Hav

e w

ritte

npr

oced

ures

on

gene

ral

mai

nten

ance

and

sani

tatio

n of

the

build

ings

, fix

ture

s, a

ndot

her

phys

ical

faci

litie

sof

the

plan

t or

veri

fyan

d ke

ep r

ecor

ds th

atfa

cilit

y ow

ner

is ta

king

prop

er m

easu

res

2639

.91

23.9

358

.38

2558

.88

38.9

076

.31

210

0.00

100.

0010

0.00

5349

.12

36.7

261

.64

Hav

e w

ritte

npr

oced

ures

on

the

stor

age

and

use

ofcl

eani

ng a

nd s

aniti

zing

mat

eria

ls o

r ve

rify

and

keep

rec

ords

that

faci

lity

owne

r is

taki

ngpr

oper

mea

sure

s

2436

.89

21.4

755

.55

2657

.32

37.1

975

.28

210

0.00

100.

0010

0.00

5246

.78

34.4

259

.55

Hav

e w

ritte

npr

oced

ures

on

pest

cont

rol o

r ve

rify

and

keep

rec

ords

that

faci

lity

owne

r is

taki

ngpr

oper

mea

sure

s

1833

.16

18.2

852

.39

3279

.57

59.4

591

.19

210

0.00

100.

0010

0.00

5254

.41

42.0

066

.29

a Pla

nts

wer

e cl

assi

fied

as o

wni

ng th

eir

faci

lity

if 50

per

cent

or

mor

e of

the

plan

t’s fa

cilit

ies

are

owne

d.


4-12

Ta

ble

4-6

. E

qu

ipm

en

t

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

Hav

e w

ritte

n pr

oced

ures

on th

e cl

eani

ng,

sani

tizin

g, a

ndm

aint

aini

ng o

feq

uipm

ent a

nd u

tens

ils

5760

.50

45.2

273

.98

9581

.04

68.3

289

.44

1310

0.00

100.

0010

0.00

165

73.8

964

.92

81.2

3

Val

idat

e th

at e

quip

men

t,in

stru

men

ts, a

nd c

ontr

ols

are

inst

alle

d co

rrec

tly

6367

.71

52.4

179

.96

7056

.25

44.3

667

.47

1185

.17

55.4

096

.37

144

62.4

053

.62

70.4

4

Val

idat

e th

at e

quip

men

t,in

stru

men

ts, a

nd c

ontr

ols

are

used

cor

rect

ly

6867

.42

51.8

479

.90

8066

.19

53.6

576

.80

1185

.17

55.4

096

.37

159

67.7

259

.01

75.3

5

Val

idat

e eq

uipm

ent u

sed

in q

ualit

y co

ntro

l55

62.9

847

.92

75.8

882

67.1

154

.22

77.8

610

77.2

047

.55

92.6

714

766

.02

56.7

774

.18


4-13

Ta

ble

4-7

. Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

Hav

e un

it or

per

son

resp

onsi

ble

for

qual

ityco

ntro

l (Q

C)

8574

.45

60.2

084

.87

108

92.3

979

.86

97.3

812

91.0

069

.49

97.8

220

584

.52

76.6

490

.08

Hav

e w

ritte

npr

oced

ures

on

the

resp

onsi

bilit

ies

and

proc

edur

es o

f the

QC

pers

on/u

nit

4864

.53

49.7

776

.96

9186

.03

75.5

492

.47

1210

0.00

100.

0010

0.00

151

78.5

970

.70

84.8

1

For

plan

ts th

at r

ecei

vein

gred

ient

s, r

equi

reso

me

or a

ll su

pplie

rs to

prov

ide

a C

ertif

icat

e of

Ana

lysi

s (C

oA)

8187

.66

75.5

494

.23

105

98.8

296

.31

99.6

312

100.

0010

0.00

100.

0019

894

.26

88.9

597

.10

For

plan

ts th

at r

equi

re a

CoA

, ver

ify r

elia

bilit

y of

supp

lier’

s C

oA

4666

.65

51.6

778

.88

8580

.62

68.8

088

.70

1087

.43

60.0

196

.99

141

75.6

267

.14

82.4

8

Con

duct

test

s on

raw

mat

eria

ls75

65.9

251

.79

77.6

899

88.0

878

.30

93.8

011

79.8

649

.47

94.1

418

578

.02

69.9

284

.42

For

plan

ts th

at te

st r

awm

ater

ials

, use

test

s to

conf

irm

iden

tity

ofin

gred

ient

s

7494

.71

70.0

799

.28

9799

.11

96.3

599

.79

1110

0.00

100.

0010

0.00

182

97.5

488

.63

99.5

1

For

plan

ts th

at te

st r

awm

ater

ials

, use

test

s to

dete

ct c

onta

min

atio

n of

raw

mat

eria

ls

7494

.71

70.0

799

.28

9697

.79

92.1

399

.40

1090

.46

53.9

198

.71

180

96.2

788

.65

98.8

4

(con

tinue

d)


4-14

Ta

ble

4-7

. Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

For

plan

ts th

at te

st r

awm

ater

ials

, use

test

s to

dete

rmin

e po

tenc

y

2838

.38

24.0

155

.11

7175

.86

63.9

384

.78

1091

.81

58.9

498

.87

109

62.9

653

.58

71.4

6

Con

duct

test

s on

in-

proc

ess

mat

eria

lsan

d/or

fini

shed

prod

ucts

6155

.81

42.0

868

.71

9179

.94

68.0

588

.17

1073

.32

44.4

290

.43

162

69.1

160

.65

76.4

5

For

plan

ts th

at te

st in

-pr

oces

s m

ater

ials

and/

or fi

nish

edpr

oduc

ts, u

se te

sts

toco

nfir

m id

entit

y of

ingr

edie

nts

5998

.14

92.7

699

.54

8595

.04

88.1

498

.01

1010

0.00

100.

0010

0.00

154

96.4

092

.34

98.3

5

For

plan

ts th

at te

st in

-pr

oces

s m

ater

ials

and/

or fi

nish

edpr

oduc

ts, u

se te

sts

tode

tect

con

tam

inat

ion

ofra

w m

ater

ials

5897

.17

91.3

499

.11

8391

.96

83.7

096

.22

989

.61

51.2

098

.61

150

93.6

588

.62

96.5

5

For

plan

ts th

at te

st in

-pr

oces

s m

ater

ials

and/

or fi

nish

edpr

oduc

ts, u

se te

sts

tode

term

ine

pote

ncy

2549

.56

32.3

866

.85

7082

.44

73.1

089

.03

1010

0.00

100.

0010

0.00

105

71.8

862

.85

79.4

4

Hol

d re

pres

enta

tive

rese

rve

sam

ples

of e

ach

batc

h

7364

.98

50.9

876

.80

9683

.67

72.2

590

.97

1072

.24

42.9

589

.99

179

74.9

566

.64

81.7

5

For

plan

ts th

at h

ave

labo

rato

ry o

pera

tions

,ha

ve w

ritte

n pr

oced

ures

for

labo

rato

ryop

erat

ions

3974

.17

61.7

383

.63

7481

.45

66.4

590

.68

993

.58

64.7

899

.14

122

80.1

070

.05

87.3

8


4-15

Ta

ble

4-8

. P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

For

plan

ts th

at r

ecei

vedi

etar

y su

pple

men

tin

gred

ient

s, h

ave

wri

tten

proc

edur

es fo

r re

ceip

t of

diet

ary

supp

lem

ent

ingr

edie

nts

5671

.08

54.4

683

.48

8692

.71

87.0

096

.03

1094

.38

68.1

699

.25

152

84.2

376

.20

89.9

2

For

plan

ts th

at h

ave

prod

uctio

n pr

oces

ses,

have

wri

tten

proc

edur

esfo

r pr

oduc

tion

proc

esse

s

6588

.43

80.9

993

.21

9490

.88

79.6

596

.21

1295

.28

72.3

599

.36

171

90.3

083

.95

94.3

1

For

plan

ts th

at h

ave

prod

uctio

n pr

oces

ses,

use

prod

uctio

n an

dpr

oces

s co

ntro

ls th

atid

entif

y th

e po

ints

, ste

ps,

or s

tage

s in

the

man

ufac

turi

ng p

roce

ss to

prev

ent a

dulte

ratio

n

4856

.99

41.7

870

.99

8377

.88

65.7

786

.58

1076

.84

50.2

591

.60

141

70.0

961

.27

77.6

4


4-16

Ta

ble

4-9

. W

are

ho

usi

ng

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

War

ehou

se h

aste

mpe

ratu

re c

ontr

ols

7274

.04

61.1

983

.77

7267

.90

56.2

077

.72

866

.39

38.3

686

.25

152

70.4

062

.28

77.4

1

War

ehou

se h

as h

umid

ityco

ntro

ls13

19.2

79.

5635

.03

2323

.54

14.5

335

.79

327

.63

9.17

59.0

739

21.9

515

.15

30.7

1

Hav

e w

ritte

n pr

oced

ures

for

stor

age

proc

edur

es to

cont

rol a

gain

stad

ulte

ratio

n as

wel

l as

dete

rior

atio

n of

the

prod

uct a

nd th

eco

ntai

ner

4749

.70

36.0

763

.37

7766

.71

54.7

776

.83

1187

.30

58.8

397

.06

135

60.6

251

.85

68.7

4

Hav

e w

ritte

n pr

oced

ures

on p

rope

r pr

ecau

tions

tore

duce

the

pote

ntia

l for

mix

-ups

or

adul

tera

tion

or c

onta

min

atio

n

5040

.31

28.5

153

.35

8676

.04

64.4

384

.75

1187

.30

58.8

397

.06

147

61.5

952

.92

69.5

8


4-17

Ta

ble

4-1

0. C

on

sum

er

Co

mp

lain

ts

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

Hav

e w

ritte

n pr

oced

ures

for

hand

ling

cons

umer

com

plai

nts

5255

.44

42.1

068

.03

8577

.68

67.2

485

.52

1395

.49

73.4

299

.39

150

68.9

560

.93

75.9

8

Proc

edur

es fo

r ha

ndlin

gad

vers

e ev

ents

ass

ocia

ted

with

con

sum

erco

mpl

aint

sa

Inci

dent

is r

epor

ted

toFD

A15

19.3

79.

9034

.43

1717

.24

9.69

28.7

95

32.1

013

.20

59.5

237

18.9

412

.70

27.3

0

Prod

uct i

s te

sted

for

iden

tity

and

com

posi

tion

6662

.40

48.4

174

.58

8373

.98

62.4

982

.91

856

.99

30.4

680

.04

157

68.0

859

.55

75.5

5

Prod

uct i

s re

form

ulat

ed19

19.2

310

.64

32.2

334

34.4

923

.93

46.8

45

34.1

314

.36

61.5

658

27.8

820

.79

36.2

8

Prod

uct i

s re

calle

d59

60.1

346

.51

72.3

575

62.6

050

.43

73.3

66

41.7

519

.33

68.2

014

060

.43

51.8

068

.47

Oth

er34

25.6

216

.25

37.9

322

22.1

513

.42

34.2

94

34.0

113

.51

62.9

760

24.2

717

.67

32.3

7

a Res

pond

ents

cou

ld s

elec

t mor

e th

an o

ne r

espo

nse.

R-1

References

Muth, M.K., and B. Wendling. 1999. “Dietary SupplementEnhanced Establishment Database, Version 1.” ResearchTriangle Park, NC: Research Triangle Institute.

Muth, M.K., S.A. Karns, and S.C. Cates. 2000. “DietarySupplement Enhanced Establishment Database, Version 2.”Research Triangle Park, NC: Research Triangle Institute.

Appendix A:Mail Survey

FRONT COVER

INSIDE COVER

Public reporting burden for this collection of information isestimated to average 1.13 hours per response, includingthe time for reviewing instructions, searching existing datasources, gathering and maintaining the data needed, andcompleting and reviewing the collection of information.Send comments regarding this burden estimate or anyother aspects of this collection of information, includingsuggestions for reducing this burden to:

Peter VardonU.S. Department of Health and Human ServicesFood and Drug Administration330 C Street, SWWashington, DC 20204

An agency may not conduct or sponsor and a person is notrequired to respond to a collection of information unless itdisplays a currently valid OMB control number.

IntroductionThe Research Triangle Institute (RTI) is conducting a survey of the dietary supplement industry aspart of a research study for the U.S. Food and Drug Administration (FDA). The purpose of thissurvey is to learn about the existing manufacturing practices in the industry. This effort is part ofthe process of considering whether to institute rulemaking to require good manufacturing practice(GMP) regulations for the dietary supplement industry.

This plant was randomly selected to participate in this survey. Please answer all questions as theypertain to the plant named on the mailing label attached to the front of this survey booklet. Plantis defined as all of the buildings and facilities, including warehouses, used in your dietarysupplement operations and within the general area of the address shown on the mailing label.

Your participation is voluntary, and your responses will be kept strictly confidential. Onlyanonymous data (no identifying information on your plant) will be provided to the FDA. Thename of your establishment will not be linked to your responses. Only aggregate results will bereported to the public.

The survey will take about an hour to complete. Please answer each question by circling theappropriate answer(s) or writing your answer in the space provided. For the purposes of thissurvey, RTI has defined many of the terms used in the survey. These definitions are provided inthe left margin. Please return the completed survey in the enclosed postage-paid returnenvelope within five business days.

If you have any questions on this research study, please contact:

Peter VardonU.S. Department of Health and Human ServicesFood and Drug Administration330 C Street, SWWashington, DC 20204Phone: 202-205-5329e-mail: [email protected]

or Heather Carter-YoungCenter for Economics ResearchResearch Triangle InstituteP.O. Box 12194Research Triangle Park, NC 27709-2194Phone: 1-800-334-8571 (ext. 8331)e-mail: [email protected]

If you have questions regarding your rights as a research participant, you may contact Dr. StevenGarfinkel at RTI (1-800-334-8571 ext. 6382).

Questions?Call the Survey Helpline (1-800-866-7655, ext. 548)

If you have any questions as you complete the survey, please call the Survey Helpline at1-800-866-7655 and ask for Michele LaPrade, extension 548. The Helpline is operated byHarris Interactive, on behalf of RTI, and operates on weekdays from 8:00 a.m. to5:00 p.m. EST.

1

1 Products and Markets

1.1 Which of the following describes the dietary supplementoperations at this plant? (Circle all that apply.)1. Manufacturer—manufacture dietary supplements from

ingredients, may package and label the product itself ortransfer it to a repackager/relabeler/encapsulator or distributor

2. Repackager/relabeler/encapsulator—repackage, relabel,or encapsulate dietary supplements manufactured by anotherfirm

3. Ingredient or input supplier—supply ingredients or bulkfinished products used to manufacture dietary supplements atthis plant or another firm

4. Distributor—distribute products manufactured by thisplant or another firm

5. Importer—import either ingredients for furtherprocessing or finished products for distribution

6. Exporter—export either ingredients for further processingor finished products for distribution

7. Other (Specify): ___________________________________

1.2 For your dietary supplement operations at this plant, what isthe product type for your primary line of business? (Circleonly one.)

(Your plant’s primary line of business for your dietarysupplement operations is defined as the one that contributesthe majority of revenues—either greater than 50% ofrevenues or the greatest of several lines such as 35% if allother lines contribute less.)1. Vitamins and minerals

2. Herbals and botanicals, not including extracts

3. Herbal and botanical extracts

4. Amino acids

5. Protein products

6. Animal extracts

7. Concentrates, metabolites, and constituents

8. Other (Specify): ___________________________________


2

1.3 What other product types, not including your primary lineof business, do you produce at this plant? By produce wemean, manufacture, repack/relabel/encapsulate, supplyingredients, distribute, import, or export. (Circle all thatapply.)1. Vitamins and minerals

2. Herbals and botanicals, not including extracts

3. Herbal and botanical extracts

4. Amino acids

5. Protein products

6. Animal extracts

7. Concentrates, metabolites, and constituents

8. Other (Specify):_________________________________________

1.4 Does this plant produce any food products other thandietary supplements?1. Yes

2. No

1.5 Does this plant produce any over-the-counter (OTC) orprescription (Rx) drugs? (Circle only one.)1. Yes, OTC drugs

2. Yes, Rx drugs

3. Yes, OTC and Rx drugs

4. No

1.6 Is this plant a member of any of the following tradeorganizations? (Circle all that apply.)1. American Herbal Products Association (AHPA)

2. Consumer Health Products Association (CHPA) (formerlyknown as Nonprescription Drug Manufacturers Association)

3. Council for Responsible Nutrition (CRN)

4. National Nutritional Foods Association (NNFA)

5. Utah Natural Products Alliance (UNPA)

6. Other (Specify):_________________________________________


3

2 Good ManufacturingPractices (GMPs)

2.1 Does this plant follow a published Good ManufacturingPractices (GMPs) model for the dietary supplementproducts produced at this plant?1. Yes

2. No Skip to question 2.3.

2.2 Which of the following are your GMPs for dietarysupplement operations patterned after? (Circle all thatapply.)1. FDA Food CGMPs (21 CFR Part 110)

2. Advance Notice of Proposed Rulemaking for DietarySupplements

3. National Nutritional Foods Association (NNFA) GMPs

4. FDA Drug CGMPs (21 CFR Parts 210 and 211)

5. U.S. Pharmacopeia (USP) GMPs

6. Other (Specify):_________________________________________

Skip to question 2.5.

2.3 If not following published GMPs, how does this plant verifythe identity, purity, and composition of dietary supplementproducts and ingredients? (Circle all that apply.)1. Sanitation standard operating procedures (SSOPs)

2. Other quality assurance (QA) program

3. Certificate of Analysis

4. Certificate of Identity

5. Other (Specify):_________________________________________

2.4 Why does this plant not follow published GMPs?__________________________________________________________

__________________________________________________________

For the purposes of thissurvey, GoodManufacturing Practices(GMPs) are the minimumsanitary and processingprocedures that a companymay have written, adopted,or may follow in practice toensure that dietarysupplements are ofconsistent quality andcontain no unintendedcomponents (for example,contaminants) that maypose a safety concern orare otherwise necessary toensure that a product is notadulterated.


4

2.5 Does this plant have standard operating procedures (SOPs)?1. Yes

2. No Skip to the STOP box below.

2.6 Is there written documentation of the SOPs?1. Yes

2. No

Please Read Before Continuing!

In Sections 3 through 9, we ask about the procedures for personnel, buildings and facilities,equipment, quality control and laboratory operations, production and process controls,warehousing, and consumer complaints to protect against adulteration and contamination. Forthe purposes of this survey, adulteration includes the presence in a product of any poisonous orharmful substance that may make the product injurious to health, the presence of filth or anyother contaminate in the product, less or more of an ingredient than the product label claims, andthe manufacture of a product in insanitary conditions in which the product may have becomecontaminated or injurious to health.

For each specific procedure (e.g., procedures for personnel on disease control, personalcleanliness, and training), we ask about the following:

Z Are there written procedures? Written procedures can include posted signs, policy andprocedure (P&P) manuals, and information posted on the company’s internal website.

Z Does plant management verify and keep records that these procedures are beingfollowed? Verification is the confirmation by examination and provision of objectiveevidence that specified requirements have been fulfilled. Verification may include directobservation of monitoring procedures, internal audits, calibration of equipment atspecified intervals, and records review. Records can include written and electronicdocumentation.

Z Are records made of any corrective actions taken if the procedures are not followed?Corrective actions are the procedures to be followed when a deviation is discoveredduring the monitoring process. Records can include written and electronicdocumentation.

Standard operatingprocedures (SOPs) detail aspecific sequence of eventsto perform a task. SOPsmay include sanitation oroperation procedures.


5

3 Personnel

3.1 Are there written procedures for personnel on diseasecontrol?1. Yes

2. No

3.2 Are there written procedures for personnel on maintainingpersonal cleanliness?1. Yes

2. No

3.3 Are there written procedures ensuring that all personnelemployed in the manufacturing process have the propereducation, training, or experience needed to perform theassigned functions?1. Yes

2. No

3.4 Does plant management verify and keep records that theprocedures for personnel on disease control, personalcleanliness, and training are being followed?1. Yes


3.5 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures

2. Yes, for all procedures

3. No

3.6 Are records maintained of personnel education, training, orexperience?1. Yes

2. No Skip to Section 4 on page 7 .

Written procedures fordisease control specify theconditions under whichemployees (includingcontract/temporarypersonnel) may not work in adietary supplement plant.This includes but is notlimited to illness; openlesions, including boils,sores, or infected wounds; orany other abnormal source ofmicrobial contamination.

Written procedures forpersonal cleanliness specifythe hygienic practicesemployees (includingcontract/ temporarypersonnel) shall follow toprotect against adulterationand contamination. Thisincludes but is not limitedto wearing outer garments,gloves, and hairnets;washing hands thoroughly;and refraining from eating,drinking, chewing gum,and using tobacco.

Written procedures foreducation, training, orexperience specify thetraining requirements foremployees (includingcontract/temporarypersonnel) and how writtenrecords of training aremaintained.


6

3.7 How long are records of personnel education, training, orexperience maintained? (Circle one and enter number ofyears if necessary.)

1. Term of employment

2. ____________ year(s) after expiration date

3. ____________ year(s) from date of manufacture

4. Other (Specify): ________________________________________________


7

4 Buildings and Facilities

4.1 What percentage of this plant’s facilities are owned vs.leased? (Include warehouse facilities located at this plant.Total should sum to 100%.)a. Owned __________% square feet

b. Leased __________% square feet

Total 100% square feet

If 50% or more of this plant’s facilities are owned, completequestions 4.2 – 4.7.

If 50% or more of this plant’s facilities are leased, completequestions 4.8 – 4.21.

Owned Facilities

4.2 Are there written procedures on maintenance of thegrounds about the plant?1. Yes

2. No

4.3 Are there written procedures on general maintenance andsanitation of the buildings, fixtures, and other physicalfacilities of the plant?1. Yes

2. No

4.4 Are there written procedures on the storage and use ofcleaning and sanitizing materials?1. Yes

2. No

Written procedures formaintenance of thegrounds specify how thegrounds about the plantshall be maintained toprotect against adulteration.This includes but is notlimited to properly storingequipment; maintainingroads, yards, and parkinglots; and maintainingadequate drainage andoperating systems for wastetreatment and disposal.

Written procedures forgeneral maintenance andsanitation of the buildings,fixtures, and other physicalfacilities specify how theplant shall be maintainedin a sanitary condition andkept in repair to preventadulteration.

Written procedures forcleaning and sanitizingmaterials specify that theybe safe and adequate underthe conditions of use andhow they shall be used,held, and stored in amanner that protectsagainst adulteration.


8

4.5 Are there written procedures on pest control?1. Yes

2. No

4.6 Does plant management verify and keep records thatprocedures for buildings and facilities maintenance arebeing followed?1. Yes

2. No Skip to Section 5 on page 11.



3. No

Skip to Section 5 on page 11.

Leased Facilities

4.8 What is the remaining term of the lease? (Enter number ofyears or months.)a. ______ years

b. ______ months

4.9 For leased facilities, who is primarily responsible formaintaining the grounds about the plant?1. Plant management (lessee)

2. Facility owner (lessor) Skip to question 4.11.

4.10 For leased facilities, are there written procedures onmaintenance of the grounds about the plant?1. Yes Skip to question 4.12.


4.11 Does plant management verify and keep records that thefacility owner is properly maintaining the grounds?1. Yes

2. No

Written procedures for pestcontrol specify whatmeasures shall be taken toexclude pests fromprocessing areas and toprotect against adulterationby pests

Written procedures formaintenance of thegrounds specify how thegrounds about the plantshall be maintained toprotect against adulteration.This includes but is notlimited to properly storingequipment; maintainingroads, yards, and parkinglots; and maintainingadequate drainage andoperating systems for wastetreatment and disposal.


9

4.12 For leased facilities, who is primarily responsible for generalmaintenance and sanitation of the buildings, fixtures, andother physical facilities of the plant?1. Plant management (lessee)


4.13 For leased facilities, are there written procedures on generalmaintenance and sanitation of the buildings, fixtures, andother physical facilities of the plant?1. Yes

2. No

4.14 For leased facilities, are there written procedures on thestorage and use of cleaning and sanitizing materials?1. Yes Skip to question 4.17.


4.15 Does plant management verify and keep records that thefacility owner is properly maintaining the buildings,fixtures, and other physical facilities of the plant?1. Yes

2. No

4.16 Does plant management verify and keep records that thecleaning and sanitizing materials used by the facility ownerare being properly stored and used?1. Yes

2. No

4.17 For leased facilities, who is primarily responsible for pestcontrol?1. Plant management (lessee)


4.18 For leased facilities, are there written procedures on pestcontrol?1. Yes Skip to question 4.20 .

2. No Skip to question 4.20 .

4.19 Does plant management verify and keep records that thefacility owner is taking proper pest control measures?1. Yes

2. No

Written procedures forgeneral maintenance andsanitation of the buildings,fixtures, and other physicalfacilities specify how theplant shall be maintainedin a sanitary condition andkept in repair to preventadulteration.

Written procedures forcleaning and sanitizingmaterials specify that theybe safe and adequate underthe conditions of use andhow they shall be used,held, and stored in amanner that protectsagainst adulteration.

Written procedures for pestcontrol specify whatmeasures shall be taken toexclude pests fromprocessing areas and toprotect against adulterationby pests.


10

4.20 Does plant management verify and keep records thatprocedures for buildings and facilities maintenance arebeing followed?1. Yes




3. No


11

5 Equipment

5.1 Are there written procedures on the cleaning, sanitizing,and maintaining of equipment and utensils?1. Yes


5.2 Does plant management verify and keep records that theseprocedures are being followed?1. Yes




3. No

5.4 Does this plant validate that equipment, instruments, andcontrols are installed correctly?1. Yes

2. No

5.5 Does this plant validate that equipment, instruments, andcontrols are used correctly?1. Yes

2. No

5.6 Does this plant validate the equipment used in qualitycontrol? Quality control equipment includes automatic,mechanical, electronic, and computer equipment, includinghardware and software.1. Yes

2. No

Written procedures forcleaning, sanitizing, andmaintaining equipment andutensils specify howequipment and utensilsshall be cleaned, sanitized,and maintained in amanner that protectsagainst adulteration.

Validation is theexamination and provisionof objective evidence thatequipment, instruments,and controls are accurate,adequately maintained, andadequate in number for theintended uses to measure,regulate, or recordtemperature, pH, wateractivity, or other condition.


12

6 Quality Control andLaboratory Operations

6.1 Is there a unit or person responsible for quality control?1. Yes


6.2 Are there written procedures on the responsibilities andprocedures required of the quality control unit/person?1. Yes

2. No

6.3 For which of the following does the quality controlunit/person have responsibility and authority? (Circle allthat apply.)1. Approval/rejection of cleaning and maintenance

procedures

2. Approval/rejection of procedures, specifications,controls, tests, and examinations for purity, quality, andcomposition

3. Approval/rejection of raw materials

4. Approval/rejection of packaging materials

5. Approval/rejection of labeling

6. Approval/rejection of finished dietary products

7. Other (Specify): ___________________________________

6.4 Does this plant require suppliers to provide a Certificate ofAnalysis? (Circle only one.)1. Yes, from some suppliers

2. Yes, from all suppliers

3. No, do not require CofA from any suppliers Skip to question 6.7.

4. Do not receive ingredients Skip to question 6.7.

6.5 Does this plant verify the reliability of the suppliers’Certificate of Analysis?1. Yes


A Certificate of Analysis isa statement from thesupplier about the identity,strength, quality, and purityof a dietary supplement rawmaterial, ingredient, orfinished product.


13

6.6 How is reliability of the suppliers’ Certificate of Analysisverified? (Circle all that apply.)1. Conduct on-site review of suppliers’ operations

2. Perform tests in-house to confirm results

3. Use off-site laboratory to confirm results

4. Require suppliers to conduct tests as part of supplyspecifications

5. Standard reference materials

6. Other (Specify):_________________________________________

6.7 Does this plant conduct tests on any raw materials? (Circleall that apply.)1. Yes, in-house

2. Yes, off-site


6.8 What percentage of raw materials are sampled and tested?(Provide average for all raw materials.)___________ % of lots

6.9 Which of the following testing techniques are used toconfirm identity of ingredients for raw materials? (Circle allthat apply.)1. Physical

2. Chemical

3. Microbiological

4. Visual (macroscopic or microscopic)

5. Organoleptic

6. No tests are conducted to confirm identity of ingredients

7. Other (Specify):_________________________________________

6.10 Which of the following testing techniques are used fordetecting contamination of raw materials? (Circle all thatapply.)1. Physical

2. Chemical

3. Microbiological


5. Organoleptic

6. No tests are conducted to detect contamination

7. Other (Specify):_________________________________________

Raw materials are anyingredients intended for usein the manufacture of adietary ingredient or dietarysupplement, includingthose that may not appearin such finished product.


14

6.11 Does this plant conduct chemical tests to determinepotency of raw materials?1. Yes

2. No

6.12 For the most recent fiscal year, approximately whatpercentage of raw materials was rejected because of thewrong identity, contamination, or potency? (If none, enterzero.)___________ % of lots If zero, skip to question 6.14.

6.13 What was the reason(s) for the rejection? (Circle all thatapply. For each item circled, enter the percentage of rawmaterials rejected for this reason. The total should sum to100%.)1. Microbial contamination ________ %

2. Pesticide, herbicide, fungicide contamination ________ %

3. Other chemical contamination ________ %

4. Wrong ingredient ________ %

5. Subpotency ________ %

6. Superpotency ________ %

7. Aflatoxin or other toxin ________ %

8. Other ________ %

Total 100%

6.14 Does this plant conduct tests on any in-process materialsand/or finished products?1. Yes


6.15 What percentage of in-process materials and/or finishedproducts are sampled and tested? (Provide an average forin-process materials and for finished products; if none, enterzero. Include continuous monitoring.)a. In-process materials: _________ % of batches

b. Finished products: _________ % of batches

In-process materials and/orfinished products are anymaterials fabricated,compounded, blended,ground, extracted, sifted,sterilized, derived bychemical reaction, orprocessed in any other waythat is produced for andused in the preparation of adietary supplement.


15

6.16 Which of the following testing techniques are used toconfirm identity of ingredients for in-process materialsand/or finished products? (Circle all that apply.)1. Physical

2. Chemical

3. Microbiological


5. Organoleptic

6. No tests are conducted to confirm identity of ingredients

7. Other (Specify): ___________________________________

6.17 Which of the following testing techniques are used fordetecting contamination of in-process materials and/orfinished products? (Circle all that apply.)1. Physical

2. Chemical

3. Microbiological


5. Organoleptic

6. No tests are conducted to detect contamination

7. Other (Specify): ___________________________________

6.18 Does this plant conduct chemical tests to determinepotency of in-process materials and/or finished products?1. Yes

2. No

6.19 For the most recent fiscal year, approximately whatpercentage of in-process materials and/or finished productswas rejected because of the wrong identity, contamination,or potency? (If none, enter zero.)a. In-process materials: _________ % of batches

b. Finished products: _________ % of batches

If zero, skip to question 6.21.


16

6.20 What was the reason(s) for the rejection? (Circle all thatapply. For each item circled, enter the percentage ofin-process materials and/or finished products rejected forthis reason. The total for each column should sum to100%.)

In-ProcessMaterials

FinishedProducts

1. Microbial contamination _______ % _______%2. Pesticide, herbicide, fungicide

contamination_______ % _______%

3. Other chemical contamination _______ % _______%4. Wrong ingredient _______ % _______%5. Subpotency _______ % _______%6. Superpotency _______ % _______%7. Formulation with missing

ingredient_______ % _______%

8. Aflatoxin or other toxin _______ % _______%9. Other _______ % _______%

Total 100% 100%

6.21 Which of the following testing methods are generally usedfor testing of raw materials, in-process materials, or finishedproducts? (Circle all that apply.)1. Association of Analytical Chemists (AOAC)

2. U.S. Pharmacopeia (USP)

3. Food Chemical CODEX (FCC)

4. American Chemical Society (ACS)

5. In-house methods

6. Other (Specify):_________________________________________

7. No testing conducted Skip to question 6.24.

6.22 Does your testing policy specify the use of standardreference materials?1. Yes


6.23 What is the source of the standard reference materials?(Circle all that apply.)1. Compendial reference standard

2. In-house primary reference materials

3. In-house working reference materials

4. Other (Specify): ___________________________________

6.24 Does your plant hold representative reserve samples of eachbatch manufactured?1. Yes



17

6.25 How long do you hold representative reserve samples?(Circle one and enter number of years.)1. ____ year(s) after expiration date

2. ____ year(s) from date of manufacture

3. Other (Specify):_________________________________________

6.26 Are there written procedures for laboratory operations?1. Yes


3. Do not have laboratory operations Skip to Section 7 on page 18.





3. No

6.29 Do your written procedures for laboratory operationsinclude any of the following? (Circle all that apply.)1. Sample selection, method description, validation of

methodology and results, acceptance/rejection criteria, and useof test results

2. Methods for determining ingredient identity and for detectingadulteration

3. Tests to assess the stability characteristics of products indetermining appropriate storage conditions and expirationdating (include testing conducted at corporate headquarters)

4. Procedures for handling and filing test records

6.30 How long are records for laboratory operations retained?(Circle one and enter number of years.)1. ____ year(s) after expiration date


3. Other (Specify):_________________________________________

6.31 Does this plant verify and keep records that laboratoryequipment is calibrated correctly?1. Yes

2. No

Written procedures forlaboratory operationsspecify the procedures thatshall be used to assure thatdietary supplementproducts conform toappropriate standards ofpurity, quality, andcomposition and thatpackaging materials aresafe and suitable for theirintended purpose.


18

7 Production and ProcessControls

7.1 Are there written procedures for receipt of dietarysupplement ingredients?1. Yes


3. Do not receive dietary supplement ingredients Skip to question 7.6.





3. No

7.4 Do your written procedures for receipt of dietarysupplement ingredients include any of the following?(Circle all that apply.)1. Written acceptance criteria for dietary supplement ingredients

developed by a competent individual

2. Certificate of Analysis specifications

3. Representative sample and authenticated plant reference heldin an environmentally appropriate repository for each receivingand production lot/batch

4. Records linking the Certificate of Analysis to the identity of theunprocessed raw material and to the finished product

5. Records to trace and verify compliance with laws on harvest ofwildcrafted botanicals

6. Audit records concerning the reliability of supplier Certificateof Analysis

7. Records for source of animal derived materials or products

8. Records for fish and fishery demonstrating that FDA fish andfishery products HACCP regulations are followed

9. Records for raw materials to assure segregation of raw, in-process, and finished product and protection againstadulteration

Written procedures forreceipt of dietarysupplement ingredientsspecify the criteria foraccepting dietarysupplement ingredients.


19

7.5 How long are records on receipt of dietary supplementingredients retained? (Circle one and enter number ofyears.)1. ____ year(s) after expiration date


3. Other (Specify): ________________________________________

7.6 Are there written procedures for production processes?1. Yes

2. No Skip to question 7.11

3. No production processes conducted Skip to Section 8 on page 21





3. No

7.9 Do your written procedures for production processesinclude any of the following? (Circle all that apply.)1. Master production and control records

2. Batch production and control records

3. Equipment use and cleaning records, including dates of useand product and lot number of each batch processed

4. Records that demonstrate that automatic equipment, includingmechanical and electronic equipment (computers), used in themanufacturing process is designed, installed, tested, calibrated,validated, maintained, and checked to ensure that they arecapable of and are performing the intended functions

5. Records for reprocessing of a product

6. Records to assure that correct labels and labeling and safepackaging materials are used

7. Records to permit tracking the history of the manufacturingprocess

8. Reserve samples of each batch of dietary supplement productare retained and stored under conditions consistent with theproduct labeling

Written procedures forproduction processesspecify the requirements ofmaster and batchproduction and controlrecords.


20

7.10 How long are records on production processes retained?(Circle one and enter number of years.)1. ____ year(s) after expiration date


3. Other (Specify):_________________________________________

7.11 Does this plant use production and process controls thatidentify the points, steps, or stages in the manufacturingprocess to prevent adulteration?1. Yes

2. No ___________________ Skip to Section 8 on page 21

7.12 Does this plant’s production and process controls havespecifications that must be met for identity, purity, quality,strength, and composition of components, ingredients, ordietary supplements and packing and labeling materials?(Circle all that apply.)1. Yes, for components

2. Yes, for ingredients

3. Yes, for dietary supplements

4. Yes, for packing and labeling materials

5. No, none of the above

7.13 Does this plant conduct tests to monitor the production andin-process control points, steps, or stages to ensure theidentity, purity, quality, strength, and composition ofcomponents, ingredients, or dietary supplements? (Circleall that apply.)1. Yes, for components

2. Yes, for ingredients

3. Yes, for dietary supplements

4. No, none of the above


21

8 Warehousing

8.1 Does your warehouse have temperature or humiditycontrols? (Circle all that apply.)1. Temperature controls

2. Humidity controls

3. No temperature or humidity controls

8.2 Are there written procedures for storage procedures tocontrol against physical, chemical, and microbialadulteration as well as deterioration of the product andcontainer?1. Yes






3. No

8.5 Do your written procedures for warehousing include any ofthe following? (Circle all that apply.)1. Procedures and records for forward and backward tracing of

product

2. Procedures and records for salvaged products that includeproduct examination and reprocessing as appropriate

Written procedures forstorage procedures specifyhow finished products shallbe stored to protect againstadulteration anddeterioration.


22

8.6 How long are records on warehousing retained? (Circle oneand enter number of years.)1. ____ year(s) after expiration date


3. Other (Specify):_________________________________________

8.7 Are there written procedures on proper precautions toreduce the potential for mix-ups or adulteration orcontamination of ingredients, raw materials, or in-processformulations (e.g., safety controls and operating practices orseparation of ingredients)?1. Yes






3. No


23

9 Consumer Complaints

9.1 Are there written procedures at the plant or corporate levelfor handling consumer complaints?1. Yes


9.2 Does management verify and keep records that theseprocedures are being followed?1. Yes




3. No

9.4 Do your written procedures for handling consumercomplaints include any of the following? (Circle all thatapply.)1. Procedures for handling all written and oral complaints

2. Records concerning the handling of complaints including anyinvestigations, investigation findings, and follow-up actiontaken

3. Procedures for requiring reporting of serious adverse events toFDA MEDWATCH

9.5 How long are records on consumer complaints retained atthe plant or corporate headquarters? (Circle one and enternumber of years.)1. ____ year(s) after expiration date


3. Other (Specify):_________________________________________

Written procedures forconsumer complaintsspecify how all written andoral complaints regardingproducts are handled.


24

9.6 What are your procedures for handling adverse eventsassociated with consumer complaints? (Circle all thatapply.)1. Incident is reported to FDA

2. Product is tested for identity and composition

3. Product is reformulated

4. Product is recalled

5. Other (Specify):_________________________________________

9.7 Does this plant have a recall procedure in place?1. Yes

2. No

9.8 Who evaluates reports on consumer complaints? (Circle allthat apply.)1. In-house medical personnel

2. In-house scientific personnel

3. In-house quality control personnel

4. In-house regulatory affairs personnel

5. Outside contractor

6. Other (Specify):_________________________________________


25

10 Your Plant

10.1 What was the calendar year during which this plant wasbuilt? (If multiple buildings, use date of oldest building.)_____________________

10.2 What was the calendar year during which the dietarysupplement operations began at this plant? (If multiplebuildings, use date of earliest operation.)_____________________

10.3 What is the total square footage of this plant? (Includewarehouse facilities.)_____________________ square feet

10.4 Are this plant’s facilities connected to a city water supply?1. Yes Skip to question 10.6.

2. No

10.5 Is the water supply at this plant potable?1. Yes

2. No

10.6 Does your company own plants at other locations?1. Yes

2. No

10.7 How many employees are currently employed at this plant?(Include contract/temporary employees.)a. Full-time _____________________

b. Part-time _____________________

10.8 How many employees employed at this plant are workingin quality control? (Include contract/temporary employees.)a. Full-time _____________________

b. Part-time _____________________


26

10.9 For the most recent fiscal year, provide the number ofbatches of dietary supplement product by product form.(Enter the number of batches for each form; if none, enterzero.)a. Powder ________ batches

b. Liquid ________ batches

c. Paste ________ batches

d. Capsule ________ batches

e. Tablet or caplet ________ batches

f. Gelcap ________ batches

g. Other (Specify):___________________________ ________ batches

h. Other (Specify):___________________________ ________ batches

Total ________ batches

10.10 What were the gross sales revenue for the dietarysupplement operations only at this plant for the most recentfiscal year? (Your responses will be kept completelyconfidential; that is, information identifying your plant willnot be linked to your responses. Do not include nonsalesrevenue such as interest income.)1. Less than $500,000

2. $500,000 to just under $1 million

3. $1 to just under $2.5 million

4. $2.5 to just under $5 million

5. $5 to just under $10 million





10. $500 million or more

Appendix B:Lead Letterand Brochure

B-1

LEAD LETTER

November 24, 1999

Quality Assurance Manager[Company][Street Address][City, State ZIP]

Dear Sir/Madam:

I am writing to ask your participation in a very important study. The Food and DrugAdministration (FDA) has contracted with the Research Triangle Institute (RTI) to conduct a nationwidesurvey of establishments that manufacture, pack, and/or hold dietary supplements. The purpose of thesurvey is to learn about the existing manufacturing practices in the dietary supplement industry. Resultsof the survey will add to the agency’s understanding of the economic impact that any proposal toestablish current Good Manufacturing Practice (cGMP) regulations may have on both large and smallfirms in the dietary supplement industry. Your establishment is among 400 dietary supplementestablishments randomly selected to participate in the survey. Your participation is crucial for itssuccess.

RTI is a not-for-profit contract research organization located in North Carolina with anestablished history of conducting economic research for FDA and other government agencies. Arepresentative from RTI will soon be calling you to ask for your cooperation. RTI will then send you acopy of the survey to complete at your convenience. The survey includes questions about yourestablishment and its manufacturing practices. After completing the survey, please return it in thepostpaid envelope provided within five business days of receipt. Individual data collected by RTI for thisstudy will be kept strictly confidential. Only anonymous data (no identifying information on your firm)will be provided to the FDA. The name of your establishment will not be linked to your responses. Allstudy participants will receive a copy of the report summarizing the survey findings.

If you have any questions about the survey, please do not hesitate to contact Peter J. Vardon withFDA, or Heather Carter-Young with RTI, both listed on the enclosed brochure, or me at(202) 205-5657. We thank you in advance for your cooperation.

Sincerely,

Richard A. Williams, Ph.D.Director, Division of Market StudiesOffice of Scientific Analysis and SupportCenter for Food Safety and Applied Nutrition

Appendix B — Lead Letter and Brochure

B-3

BROCHURE


B-4

BROCHURE (CONTINUED)

Appendix C:WeightingProcedures

C-1

Survey weights were computed in several steps:

1. Initial sampling weights were computed to reflect the differentprobabilities of selection induced by the sampling design (i.e.,by using different sampling rates in the various strata).

2. We then used weighting classes to adjust these weights fornonresponse to the initial telephone interview.

3. Because our population included Canadian establishments thatwere not eligible for the survey, we post-stratified to adjust tothe population size excluding Canadian establishments.

4. We made a second nonresponse adjustment for nonresponse tothe mail survey.

Nonresponse adjustments ensure that, within each weighting class,respondent weights sum to the population counts of eligibleestablishments. These adjustments, implemented with thecomputation and application of adjustment factors in each class,also tend to reduce the biases of nonresponse to the extent thatweighting classes are homogeneous.

We describe each step in more detail below.

C.1 INITIAL SAMPLING WEIGHTSWe first assigned each selected establishment (i.e., sample point) aninitial sampling weight. The initial sampling weight is equal to theinverse of the selection probability where the selection probabilityis equal to the stratum sample size (n) divided by the stratumpopulation (N). Thus, for each of the 16 product type and sizesampling stratum we calculated the initial sampling weights asfollows:

W0 = population size (N) for stratum

sample size (n) for stratum (C.1)

The sum of the initial sampling weights across all sampledestablishments in a stratum is equal to the population for thatstratum.


C-2

C.2 NONRESPONSE ADJUSTMENT FOR INITIALTELEPHONE INTERVIEW (PART 1)Next, we adjusted the initial sampling weights for nonresponse tothe initial telephone interview (Part 1). To reduce the potential biascaused by nonresponse, we divided the population into mutuallyexclusive groups or weighting classes. We then adjusted thesampling weights of responding establishments in each weightingclass so that the sum of the weights equals the number of eligibleestablishments in the weighting class.

We defined the weighting classes by collapsing the 16 samplingstrata into 9 weighting classes. We collapsed strata or cells if therewere less than 20 Part 1 respondents in a cell. Because of theunique characteristics of large establishments and the small numberof large respondents, we defined one weighting class for largerespondents. For the vitamins and minerals and the other producttype categories, we collapsed the very smalls and unknowns intoone weighting class. For the amino acids/proteins/animal extractsproduct type, we collapsed the very smalls, smalls, and unknownsinto one weighting class.

We calculated adjustment factors (F1) within each of the nineweighting classes as follows:

F1 = sum of weights (W0) for eligibles in class

sum of weights (W0) for respondentsPart 1 in class (C.2)

The adjusted weight for each responding establishment in aweighting class is equal to

W1 = W0 • F1 (C.3)

C.3 POST-STRATIFICATION ADJUSTMENTBecause our population included Canadian establishments thatwere not eligible for the survey, we post-stratificatied to adjust tothe population size excluding Canadian establishments. We usedthe same weighting classes for this adjustment as described above.The post-stratification adjustment factor for each weighting class isequal to

Appendix C — Weighting Procedures

C-3

F2 =

revised population size in class (excludes Canadian establishments)sum of weights for non-Canadian

respondents and ineligibles in class1

(C.4)

The adjusted weight for each responding establishment in aweighting class is equal to

W2 = W1 • F2 (C.5)

C.4 NONRESPONSE ADJUSTMENT FOR MAILSURVEY (PART 2)We adjusted the sampling weights for nonresponse to the mailsurvey using the same approach described for Part 1. Because ofthe small number of respondents in the other product type category,we collapsed the two weighting classes into one, for a total of eightweighting classes for the Part 2 nonresponse adjustment.

We calculated adjustment factors (F3) within each weighting classas follows:

F3 =

sum of W2 weights foreligible respondentsPart 1 in class

sum of W2 weights for respondentsPart 2 in class

(C.6)

The final adjusted weight (W3) for each responding establishmentin a weighting class is equal to

W3 = W2 • F3 (C.7)

After computing the weights, we found that one respondent had arelatively large weight. This company was the only respondent inthe vitamin and minerals/unknown stratum, and it was in thevitamin and minerals and small analysis domains. We computedunequal weighting design effects with and without this observationincluded in the analysis domains to determine the impact of theunequal weights. We found that the difference in design effectswas significant. To correct for this, for weighting purposes wemoved this respondent from the vitamin and minerals/unknownstratum to the vitamin and mineral/small stratum (to match the

1For the post-stratification adjustment we included ineligibles since the population

we are adjusting to includes ineligibles.


C-4

respondent’s reporting domain) and assigned the correspondinginitial weight. We then re-computed the weights for the vitaminand minerals stratum. The weights for the other product types didnot change.

We weighted all results using the final adjusted weights (W3). Thesum of the final adjusted weights across all respondents to the mailsurvey is equal to the population of eligible establishments.Table C-1 shows the estimated eligible population by the producttype and establishment size reporting domains (as defined inSection 4).

Table C-1. Estimated Eligible Population

Number ofRespondents

Estimated EligiblePopulation

Product Type

Vitamins and Minerals 118 610

Amino Acids/Proteins/Animal Extracts 16 36

Herbals and Botanicals 97 243

Other 7 17

Total 238 906

Establishment Size

Very Small 110 394

Small 114 465

Large 14 47

Total 238 906

Appendix D:Weighted Results byEstablishment Size

D-1

The results for each section of the survey are reported in a separatetable (e.g., Table D-1 corresponds to Section 1 of the survey). Foreach question response item, we provide the number ofrespondents who circled that answer (n), the proportion ofrespondents who circled that answer (%), and the 95 percentconfidence interval for the point estimate (Low and High values).Where appropriate, we report the mean response.

The totals for a question may not always sum to 100 percent due torounding. We have indicated with an (*) when respondents couldselect more than one response.

Because of the skip patterns, the number of respondents varies byquestion. We excluded from the analysis respondents whoappropriately skipped questions. For example, respondents whoanswered 2 (No) to Question 2.5 were not included in thefrequency for Question 2.6.


D-2

Ta

ble

D-1

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

1: P

rod

uc

ts a

nd

Ma

rke

ts

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

1.1*

Whi

ch o

f the

follo

win

g de

scri

bes

the

diet

ary

supp

lem

ent o

pera

tions

at

this

pla

nt?

1.M

anuf

actu

rer—

man

ufac

ture

diet

ary

supp

lem

ents

from

ingr

edie

nts,

may

pac

kage

and

labe

l the

pro

duct

itse

lf or

tran

sfer

it to

a r

epac

kage

r/re

labe

ler/

enca

psul

ator

or

dist

ribu

tor

6253

.49

39.8

766

.62

7568

.51

56.6

278

.39

962

.59

34.8

083

.98

146

61.6

853

.00

69.6

7

2.R

epac

kage

r/ r

elab

eler

/en

caps

ulat

or—

repa

ckag

e,re

labe

l, or

enc

apsu

late

die

tary

supp

lem

ents

man

ufac

ture

d by

anot

her

firm

2326

.64

15.9

640

.99

4141

.51

30.2

553

.74

323

.50

7.35

54.3

367

34.1

126

.27

42.9

3

3.In

gred

ient

or

inpu

t sup

plie

r—su

pply

ingr

edie

nts

or b

ulk

finis

hed

prod

ucts

use

d to

man

ufac

ture

die

tary

sup

plem

ents

at th

is p

lant

or

anot

her

firm

3021

.92

13.2

833

.98

4538

.63

27.7

550

.79

430

.48

11.8

158

.95

7930

.94

23.5

439

.48

4.D

istr

ibut

or—

dist

ribu

te p

rodu

cts

man

ufac

ture

d by

this

pla

nt o

ran

othe

r fir

m

5956

.64

43.0

969

.27

7057

.07

44.9

668

.39

642

.14

19.4

568

.73

135

56.1

047

.35

64.4

9

5.Im

port

er—

impo

rt e

ither

ingr

edie

nts

for

furt

her

proc

essi

ngor

fini

shed

pro

duct

s fo

rdi

stri

butio

n

2823

.47

14.0

636

.50

4035

.00

24.4

247

.31

537

.66

16.1

865

.40

7330

.13

22.7

238

.75

6.Ex

port

er—

expo

rt e

ither

ingr

edie

nts

for

furt

her

proc

essi

ngor

fini

shed

pro

duct

s fo

rdi

stri

butio

n

3129

.14

18.2

343

.13

4337

.47

26.6

949

.66

642

.83

20.0

269

.17

8034

.13

26.4

242

.79

7.O

ther

73.

641.

737.

513

4.58

1.15

16.5

20

0.00

0.00

0.00

103.

931.

629.

21

No

answ

er1

0.54

0.07

3.82

11.

140.

167.

810

0.00

0.00

0.00

20.

820.

183.

67

(con

tinue

d)

Appendix D — Weighted Results by Establishment Size

D-3

Ta

ble

D-1

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

1: P

rod

uc

ts a

nd

Ma

rke

ts (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

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wH

igh

1.2

For

you

r di

etar

y su

pple

men

top

erat

ions

at t

his

plan

t, w

hat i

s th

epr

oduc

t typ

e fo

r yo

ur p

rim

ary

line

ofbu

sine

ss?a

1.V

itam

ins

and

min

eral

s15

24.1

313

.49

39.3

636

42.3

531

.35

54.1

69

68.5

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460

35.8

128

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44.2

2

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erba

ls a

nd b

otan

ical

s, n

otin

clud

ing

extr

acts

3225

.98

16.0

239

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2417

.81

10.5

128

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217

.68

4.31

50.6

158

21.3

515

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29.1

2

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erba

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anic

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xtra

cts

3926

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6126

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min

o ac

ids

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3.77

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6427

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5.Pr

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n pr

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once

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and

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titue

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561

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60

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42.

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65

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ther

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Res

pond

ent s

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ted

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tiple

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onse

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7111

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-die

tary

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ent p

rodu

ct1

0.57

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20.

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94

No

answ

er1

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0.07

3.82

00.

000.

000.

000

0.00

0.00

0.00

10.

240.

031.

67

(con

tinue

d)


D-4

Ta

ble

D-1

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

1: P

rod

uc

ts a

nd

Ma

rke

ts (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

1.3*

Wha

t oth

er p

rodu

ct ty

pes,

not

incl

udin

g yo

ur p

rim

ary

line

ofbu

sine

ss, d

o yo

u pr

oduc

e at

this

plan

t? B

y pr

oduc

e w

e m

ean,

man

ufac

ture

, rep

ack/

rela

bel/

enca

psul

ate,

sup

ply

ingr

edie

nts,

dist

ribu

te, i

mpo

rt, o

r ex

port

.

1.V

itam

ins

and

min

eral

s23

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018

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45.2

734

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323

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46.9

11

11.1

51.

5649

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440

.36

2.H

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ls a

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otan

ical

s, n

otin

clud

ing

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acts

3238

.86

26.2

453

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6162

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51.0

172

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430

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11.8

158

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9750

.50

42.1

858

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3.H

erba

l and

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anic

al e

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2824

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137

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37.5

461

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322

.86

7.46

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785

37.0

929

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6

4.A

min

o ac

ids

1316

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8.28

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940

46.1

334

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43.

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5.Pr

otei

n pr

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2025

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447

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832

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6.A

nim

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0.00

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2716

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7.C

once

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ites,

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7420

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ther

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Non

-die

tary

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plem

ent p

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ct8

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No

othe

r pr

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t typ

es32

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30.8

813

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54.

8519

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319

.73

6.12

48.0

748

15.1

510

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4

1.4

Doe

s th

is p

lant

pro

duce

any

food

prod

ucts

oth

er th

an d

ieta

rysu

pple

men

ts?

1.Y

es12

6.81

3.77

11.9

939

32.2

822

.26

44.2

51

7.62

1.03

39.4

752

19.9

214

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27.2

2

2.N

o96

91.8

686

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95.2

874

66.5

854

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76.7

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Don

’t kn

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240.

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67

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answ

er1

0.79

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140.

167.

810

0.00

0.00

0.00

20.

930.

223.

86

(con

tinue

d)


D-5

Ta

ble

D-1

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

1: P

rod

uc

ts a

nd

Ma

rke

ts (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

1.5

Doe

s th

is p

lant

pro

duce

any

ove

r-th

e-co

unte

r (O

TC) o

r pr

escr

iptio

n(R

x) d

rugs

?

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es, O

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rugs

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123.

0112

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1711

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6.75

18.6

74

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011

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3.Y

es, O

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nd R

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754.

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1.6*

Is

this

pla

nt a

mem

ber

of a

ny o

f the

follo

win

g tr

ade

orga

niza

tions

?

1.A

mer

ican

Her

bal P

rodu

cts

Ass

ocia

tion

(AH

PA)

4023

.69

16.7

432

.40

4125

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18.0

334

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211

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2.65

36.0

383

23.8

519

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29.1

3

2.C

onsu

mer

Hea

lth P

rodu

cts

Ass

ocia

tion

(CH

PA) (

form

erly

know

n as

Non

pres

crip

tion

Dru

gM

anuf

actu

rers

Ass

ocia

tion)

34.

791.

0719

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96.

843.

3313

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427

.35

10.1

755

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167.

033.

8512

.51

3.C

ounc

il fo

r R

espo

nsib

leN

utri

tion

(CR

N)

710

.39

3.95

24.6

620

20.8

212

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32.4

75

34.9

714

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62.5

232

17.0

311

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24.8

0

4.N

atio

nal N

utri

tiona

l Foo

dsA

ssoc

iatio

n (N

NFA

)44

40.0

227

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44

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7354

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5.U

tah

Nat

ural

Pro

duct

s A

llian

ce(U

NPA

)1

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3.66

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ther

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6.25

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app

licab

le35

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120

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826

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0.00

0.00

10.

240.

031.

67

a The

pri

mar

y lin

e of

bus

ines

s is

the

line

of b

usin

ess

that

con

trib

utes

to th

e m

ajor

ity o

f rev

enue

s—ei

ther

gre

ater

than

50

perc

ent o

f rev

enue

s or

the

grea

test

of s

ever

allin

es s

uch

as 3

5 pe

rcen

t if a

ll ot

her

lines

con

trib

ute

less

.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


D-6

Ta

ble

D-2

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

2: G

oo

d M

an

ufa

ctu

rin

g P

rac

tic

es

(GM

Ps)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

2.1

Doe

s th

is p

lant

follo

w a

pub

lishe

dG

ood

Man

ufac

turi

ng P

ract

ices

(GM

Ps) m

odel

for

the

diet

ary

supp

lem

ent p

rodu

cts

prod

uced

at

this

pla

nt?

1.Y

es61

51.7

638

.26

65.0

286

72.9

760

.63

82.5

512

88.9

863

.97

97.3

515

964

.60

56.0

972

.27

2.N

o (S

kip

to q

uest

ion

2.3)

3941

.82

29.0

555

.79

2423

.83

14.7

236

.19

00.

000.

000.

0063

30.3

923

.11

38.8

2

Not

app

licab

le (S

kip

to q

uest

ion

2.3)

63.

221.

447.

031

0.48

0.07

3.41

16.

540.

9034

.91

81.

991.

003.

93

No

answ

er4

3.20

1.09

9.00

32.

720.

818.

771

4.49

0.61

26.4

78

3.02

1.42

6.31

2.2*

[If

2.1

is Y

es]

Whi

ch o

f the

follo

win

g ar

e yo

urG

MPs

for

diet

ary

supp

lem

ent

oper

atio

ns p

atte

rned

afte

r?

1.FD

A F

ood

CG

MPs

(21

CFR

Par

t11

0)41

68.5

549

.65

82.8

152

63.9

951

.66

74.7

26

51.8

624

.92

77.7

599

64.7

055

.38

73.0

3

2.A

dvan

ce N

otic

e of

Pro

pose

dR

ulem

akin

g fo

r D

ieta

rySu

pple

men

ts

1425

.99

12.4

646

.42

2333

.09

21.2

147

.61

438

.22

15.1

668

.19

4130

.99

21.9

241

.81

3.N

atio

nal N

utri

tiona

l Foo

dsA

ssoc

iatio

n (N

NFA

) GM

Ps13

27.7

313

.66

48.2

125

30.1

619

.33

43.7

71

8.57

1.14

43.1

239

27.7

519

.09

38.4

7

4.FD

A D

rug

CG

MPs

(21

CFR

Par

ts21

0 an

d 21

1)10

16.6

66.

7235

.71

2933

.57

22.1

847

.26

973

.84

41.2

291

.91

4830

.59

22.0

940

.67

5.U

.S. P

harm

acop

eia

(USP

) GM

Ps10

16.5

66.

6435

.65

2536

.72

24.9

250

.37

756

.71

28.3

181

.29

4231

.15

22.3

941

.50

6.O

ther

1020

.46

8.52

41.5

47

4.76

2.01

10.8

31

8.57

1.14

43.1

218

10.5

05.

4519

.27

Don

’t kn

ow1

1.05

0.14

7.30

00.

000.

000.

000

0.00

0.00

0.00

10.

360.

052.

59

No

answ

er1

1.00

0.14

7.01

00.

000.

000.

000

0.00

0.00

0.00

10.

350.

052.

48

(Ski

p to

que

stio

n 2.

5)

(con

tinue

d)


D-7

Ta

ble

D-2

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

2: G

oo

d M

an

ufa

ctu

rin

g P

rac

tic

es

(GM

Ps)

(c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

2.3*

[If

2.1

is N

o]If

not f

ollo

win

g pu

blis

hed

GM

Ps,

how

doe

s th

is p

lant

ver

ify th

eid

entit

y, p

urity

, and

com

posi

tion

ofdi

etar

y su

pple

men

t pro

duct

s an

din

gred

ient

s?

1.Sa

nita

tion

stan

dard

ope

ratin

gpr

oced

ures

(SSO

Ps)

822

.56

——

a6

14.1

8—

—a

—b

——

—14

19.0

9—

—a

2.O

ther

qua

lity

assu

ranc

e (Q

A)

prog

ram

1120

.18

——

a9

33.9

9—

—a

—b

——

—20

25.2

9—

—a

3.C

ertif

icat

e of

Ana

lysi

s27

64.5

5—

—a

1985

.73

——

a—

b—

——

4672

.02

——

a

4.C

ertif

icat

e of

Iden

tity

1011

.96

——

a6

23.6

6—

—a

—b

——

—16

16.3

4—

—a

5.O

ther

1745

.57

——

a7

24.7

0—

—a

—b

——

—24

37.0

5—

—a

Not

app

licab

le6

13.5

0—

—a

0—

——

a—

b—

——

79.

22—

—a

No

answ

er1

1.27

——

a0

——

—a

—b

——

—1

0.77

——

a

2.4

[If

2.1

is N

o]W

hy d

oes

this

pla

nt n

ot fo

llow

publ

ishe

d G

MPs

?

(ver

batim

s pr

ovid

ed in

Tab

le D

-11)

2.5

Doe

s th

is p

lant

hav

e st

anda

rdop

erat

ing

proc

edur

es (S

OPs

)?

1.Y

es79

65.1

750

.98

77.1

010

491

.11

81.0

896

.08

1288

.98

63.9

797

.35

195

79.7

371

.54

86.0

2

2.N

o (S

kip

to S

ectio

n 3)

1922

.27

12.3

536

.82

55.

201.

5216

.28

00.

000.

000.

0024

12.3

47.

2920

.14

Not

app

licab

le5

2.87

1.16

6.91

00.

000.

000.

001

6.54

0.90

34.9

16

1.59

0.71

3.52

Don

’t kn

ow1

0.52

0.07

3.66

00.

000.

000.

000

0.00

0.00

0.00

10.

230.

031.

60

No

answ

er6

9.18

3.17

23.7

95

3.69

1.40

9.37

14.

490.

6126

.47

126.

112.

8412

.65

(con

tinue

d)


D-8

Ta

ble

D-2

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

2: G

oo

d M

an

ufa

ctu

rin

g P

rac

tic

es

(GM

Ps)

(c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

2.6

[If

2.5

is Y

es]

Is th

ere

wri

tten

docu

men

tatio

n of

the

SOPs

?

1.Y

es62

81.5

767

.04

90.5

986

81.3

368

.89

89.5

511

91.4

357

.02

98.8

515

982

.01

73.4

788

.24

2.N

o10

7.86

4.15

14.3

89

12.1

65.

4225

.08

00.

000.

000.

0019

9.92

5.34

17.6

9

Don

’t kn

ow1

0.83

0.11

5.82

00.

000.

000.

000

0.00

0.00

0.00

10.

300.

042.

10

No

answ

er6

9.75

3.05

27.0

29

6.51

3.09

13.1

91

8.57

1.15

42.9

816

7.78

4.05

14.4

2

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.b C

ould

not

est

imat

e be

caus

e th

ere

wer

e no

res

pond

ents

for

that

que

stio

n.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


D-9

Ta

ble

D-3

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

3: P

ers

on

ne

l

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

3.0

Do

pers

onne

l at t

his

plan

t or

site

hand

le r

aw m

ater

ials

, in-

proc

ess

mat

eria

ls, o

r fin

ishe

d pr

oduc

ts,

incl

udin

g di

stri

butio

n of

fini

shed

prod

ucts

?

1.Y

es96

83.1

968

.87

91.7

210

996

.94

92.0

598

.86

1395

.51

73.5

399

.39

218

90.9

083

.90

95.0

3

2.N

o (S

kip

to S

ectio

n 4)

1416

.81

8.28

31.1

35

3.06

1.14

7.95

14.

490.

6126

.47

209.

104.

9716

.10

3.1

Are

ther

e w

ritte

n pr

oced

ures

for

pers

onne

l on

dise

ase

cont

rol?

1.Y

es47

55.7

441

.51

69.0

974

71.1

758

.99

80.9

013

100.

0010

0.00

100.

0013

466

.62

57.9

674

.29

2.N

o47

43.0

129

.81

57.2

935

28.8

319

.10

41.0

10

0.00

0.00

0.00

8232

.88

25.2

441

.55

Not

app

licab

le2

1.25

0.31

4.92

00.

000.

000.

000

0.00

0.00

0.00

20.

500.

121.

96

3.2

Are

ther

e w

ritte

n pr

oced

ures

for

pers

onne

l on

mai

ntai

ning

per

sona

lcl

eanl

ines

s?

1.Y

es67

69.8

055

.01

81.3

895

84.9

972

.39

92.4

413

100.

0010

0.00

100.

0017

579

.78

71.4

486

.16

2.N

o27

28.9

517

.55

43.8

214

15.0

17.

5627

.61

00.

000.

000.

0041

19.7

313

.39

28.0

8

Not

app

licab

le2

1.25

0.31

4.92

00.

000.

000.

000

0.00

0.00

0.00

20.

500.

121.

96

3.3

Are

ther

e w

ritte

n pr

oced

ures

ensu

ring

that

all

pers

onne

lem

ploy

ed in

the

man

ufac

turi

ngpr

oces

s ha

ve th

e pr

oper

edu

catio

n,tr

aini

ng, o

r ex

peri

ence

nee

ded

tope

rfor

m th

e as

sign

ed fu

nctio

ns?

1.Y

es53

53.9

539

.41

67.8

482

70.9

858

.20

81.1

212

93.1

563

.84

99.0

614

765

.43

56.3

773

.49

2.N

o38

39.2

126

.19

53.9

627

29.0

218

.88

41.8

00

0.00

0.00

0.00

6531

.47

23.6

340

.53

Not

app

licab

le4

2.66

0.94

7.31

00.

000.

000.

001

6.85

0.94

36.1

65

1.43

0.58

3.49

No

answ

er1

4.19

0.58

24.8

40

0.00

0.00

0.00

00.

000.

000.

001

1.67

0.23

11.1

8

(con

tinue

d)


D-10

Ta

ble

D-3

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

3: P

ers

on

ne

l (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

3.4

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at th

e pr

oced

ures

for

pers

onne

l on

dise

ase

cont

rol,

pers

onal

cle

anlin

ess,

and

trai

ning

are

bein

g fo

llow

ed?

1.Y

es45

47.6

833

.87

61.8

575

69.3

156

.93

79.4

212

93.1

563

.84

99.0

613

262

.02

53.1

370

.18

2.N

o (S

kip

to q

uest

ion

3.6)

4642

.04

28.9

756

.34

3430

.69

20.5

843

.07

00.

000.

000.

0080

33.5

125

.71

42.3

3

Not

app

licab

le2

1.25

0.31

4.92

00.

000.

000.

001

6.85

0.94

36.1

63

0.87

0.27

2.77

No

answ

er3

9.03

2.56

27.2

80

0.00

0.00

0.00

00.

000.

000.

003

3.59

1.00

12.0

8

3.5

[If

3.4

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es24

58.2

136

.93

76.8

238

47.7

733

.56

62.3

55

43.2

918

.65

71.7

767

50.5

939

.34

61.7

8

2.Y

es, f

or a

ll pr

oced

ures

1221

.94

10.2

240

.97

2233

.07

20.3

348

.88

756

.71

28.2

381

.35

4131

.63

21.9

943

.15

3.N

o6

15.1

14.

5140

.13

913

.94

6.68

26.8

00

0.00

0.00

0.00

1513

.14

6.83

23.7

9

No

answ

er3

4.74

1.39

14.9

86

5.22

2.19

11.9

50

0.00

0.00

0.00

94.

642.

329.

07

3.6

Are

rec

ords

mai

ntai

ned

of p

erso

nnel

educ

atio

n, tr

aini

ng, o

r ex

peri

ence

?

1.Y

es54

54.2

239

.63

68.1

284

73.6

661

.31

83.1

512

93.1

563

.84

99.0

615

067

.00

57.9

974

.92

2.N

o (S

kip

to S

ectio

n 4)

4044

.51

30.7

159

.20

2526

.34

16.8

538

.69

00.

000.

000.

0065

32.1

124

.23

41.1

7

Not

app

licab

le2

1.28

0.31

5.09

00.

000.

000.

001

6.85

0.94

36.1

63

0.88

0.27

2.81

(con

tinue

d)


D-11

Ta

ble

D-3

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

3: P

ers

on

ne

l (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

3.7

[If

3.6

is Y

es]

How

long

are

rec

ords

of p

erso

nnel

educ

atio

n, tr

aini

ng, o

r ex

peri

ence

mai

ntai

ned?

1.Te

rm o

f em

ploy

men

t36

71.5

7—

—a

4755

.69

——

a4

34.2

6—

—a

8759

.16

——

a

2.__

_ Y

ear(

s) a

fter

expi

ratio

n da

te2

2.30

——

a7

9.75

——

a1

8.57

——

a10

7.26

——

a

3.__

_ Y

ear(

s) fr

om d

ate

ofm

anuf

actu

re3

3.67

——

a5

7.90

——

a0

0.00

——

a8

5.94

——

a

4.O

ther

1221

.31

——

a20

22.9

0—

—a

652

.10

——

a38

24.6

3—

—a

Don

’t kn

ow0

0.00

——

a0

0.00

——

a1

5.07

——

a1

0.39

——

a

No

answ

er1

1.15

——

a5

3.76

——

a0

0.00

——

a6

2.63

——

a

Mea

n ye

ars

afte

r ex

pira

tion

date

22.

50—

—a

72.

14—

—a

16.

00—

—a

102.

53—

—a

Mea

n ye

ars

from

dat

e of

man

ufac

ture

32.

67—

—a

53.

74—

—a

—b

——

—8

3.52

——

a

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.b C

ould

not

est

imat

e be

caus

e th

ere

wer

e no

res

pond

ents

for

that

que

stio

n.


D-12

Ta

ble

D-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.0

Are

raw

mat

eria

ls, i

n-pr

oces

sm

ater

ials

, or

finis

hed

prod

ucts

hand

led

or s

tore

d at

this

pla

nt o

rsi

te?

1.Y

es10

192

.04

80.7

896

.95

111

98.1

093

.12

99.4

913

95.5

173

.53

99.3

922

595

.33

90.2

197

.84

2.N

o (S

kip

to S

ectio

n 5)

97.

963.

0519

.22

31.

900.

516.

881

4.49

0.61

26.4

713

4.67

2.16

9.79

4.1

Wha

t per

cent

age

of p

lant

s ar

eow

ned

vs. l

ease

d?b

(Inc

lude

war

ehou

se fa

cilit

ies

loca

ted

at th

ispl

ant.)

a.O

wne

d39

36.1

024

.01

50.2

768

59.8

047

.47

71.0

011

85.1

755

.41

96.3

711

851

.19

42.4

359

.88

b.Le

ased

6263

.90

49.7

375

.99

4340

.20

29.0

052

.53

214

.83

3.63

44.5

910

748

.81

40.1

257

.57

Ow

ned

Faci

litie

s

4.2

Are

ther

e w

ritte

n pr

oced

ures

on

mai

nten

ance

of t

he g

roun

ds a

bout

the

plan

t?

1.Y

es9

24.3

39.

4949

.63

3860

.35

45.3

473

.64

1090

.63

53.8

798

.77

5752

.35

40.6

563

.79

2.N

o27

70.9

246

.84

87.1

029

37.7

024

.69

52.7

71

9.37

1.23

46.1

357

45.0

533

.75

56.8

8

Not

app

licab

le1

1.63

0.22

11.2

90

0.00

0.00

0.00

00.

000.

000.

001

0.48

0.07

3.43

Don

’t kn

ow1

1.56

0.21

10.8

00

0.00

0.00

0.00

00.

000.

000.

001

0.46

0.06

3.29

No

answ

er1

1.56

0.21

10.8

01

1.94

0.26

12.9

80

0.00

0.00

0.00

21.

660.

357.

42

(con

tinue

d)


D-13

Ta

ble

D-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.3

Are

ther

e w

ritte

n pr

oced

ures

on

gene

ral m

aint

enan

ce a

nd s

anita

tion

of th

e bu

ildin

gs, f

ixtu

res,

and

oth

erph

ysic

al fa

cilit

ies

of th

e pl

ant?

1.Y

es20

61.2

241

.95

77.5

254

79.3

563

.66

89.3

910

94.4

668

.48

99.2

684

75.3

164

.74

83.5

1

2.N

o17

35.5

919

.93

55.0

814

20.6

510

.61

36.3

41

5.54

0.74

31.5

232

23.7

515

.60

34.4

2

Not

app

licab

le2

3.19

0.75

12.6

40

0.00

0.00

0.00

00.

000.

000.

002

0.94

0.23

3.78

4.4

Are

ther

e w

ritte

n pr

oced

ures

on

the

stor

age

and

use

of c

lean

ing

and

sani

tizin

g m

ater

ials

?

1.Y

es16

52.8

231

.31

73.3

347

69.3

352

.88

81.9

911

100.

0010

0.00

100.

0074

67.1

355

.17

77.2

2

2.N

o21

43.9

924

.16

65.9

421

30.6

718

.01

47.1

20

0.00

0.00

0.00

4231

.93

21.8

843

.98

Not

app

licab

le2

3.19

0.75

12.6

40

0.00

0.00

0.00

00.

000.

000.

002

0.94

0.23

3.78

4.5

Are

ther

e w

ritte

n pr

oced

ures

on

pest

cont

rol?

1.Y

es20

59.4

037

.16

78.3

652

77.2

761

.84

87.6

910

94.4

668

.48

99.2

682

73.4

862

.04

82.4

5

2.N

o17

37.4

119

.14

60.1

516

22.7

312

.31

38.1

61

5.54

0.74

31.5

234

25.5

716

.67

37.1

1

Not

app

licab

le1

1.56

0.21

10.8

00

0.00

0.00

0.00

00.

000.

000.

001

0.46

0.06

3.29

No

answ

er1

1.63

0.22

11.2

90

0.00

0.00

0.00

00.

000.

000.

001

0.48

0.07

3.43

4.6

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at p

roce

dure

s fo

rbu

ildin

gs a

nd fa

cilit

ies

mai

nten

ance

are

bein

g fo

llow

ed?

1.Y

es15

52.5

133

.50

70.8

250

78.4

463

.61

88.3

49

81.2

647

.18

95.4

774

71.0

261

.23

79.1

8

2.N

o (S

kip

to S

ectio

n 5)

2345

.86

27.8

964

.97

1821

.56

11.6

636

.39

218

.74

4.53

52.8

243

28.5

020

.34

38.3

6

No

answ

er1

1.63

0.22

11.2

90

0.00

0.00

0.00

00.

000.

000.

001

0.48

0.07

3.43

(con

tinue

d)


D-14

Ta

ble

D-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.7

[If

4.6

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es7

24.7

311

.32

45.8

126

53.2

636

.07

69.7

12

23.6

85.

1863

.81

3544

.06

29.7

759

.40

2.Y

es, f

or a

ll pr

oced

ures

429

.24

6.60

70.7

215

31.3

717

.34

49.9

07

76.3

236

.19

94.8

226

35.4

122

.58

50.7

4

3.N

o1

2.97

0.37

20.1

16

10.8

44.

5223

.80

00.

000.

000.

007

8.03

3.59

16.9

8

No

answ

er3

43.0

613

.56

78.4

83

4.53

1.24

15.1

80

0.00

0.00

0.00

612

.51

4.56

29.9

5

Leas

ed F

acili

ties

4.8

Wha

t is

the

rem

aini

ng te

rm o

f the

leas

e? Yea

rs (m

ean

resp

onse

)55

3.04

——

a41

4.63

——

a1

0.00

——

a97

3.77

——

a

Ope

n le

ase

(%)

54.

591.

9110

.60

11.

230.

168.

560

0.00

0.00

0.00

63.

051.

446.

34

4.9

For

leas

ed fa

cilit

ies,

who

is p

rim

arily

resp

onsi

ble

for

mai

ntai

ning

the

grou

nds

abou

t the

pla

nt?

1.Pl

ant m

anag

emen

t (le

ssee

)21

31.9

917

.69

50.7

226

57.5

737

.64

75.3

01

53.8

26.

5895

.07

4843

.46

31.1

556

.64

2.Fa

cilit

y ow

ner

(less

or) (

Skip

toqu

estio

n 4.

11)

4062

.08

42.9

178

.10

1639

.54

22.3

359

.81

146

.18

4.93

93.4

257

52.0

338

.75

65.0

2

No

answ

er1

5.93

0.78

33.5

41

2.89

0.38

18.8

20

0.00

0.00

0.00

24.

510.

9419

.09

4.10

[If

4.9

is 1

(les

see)

]Fo

r le

ased

faci

litie

s, a

re th

ere

wri

tten

proc

edur

es o

n m

aint

enan

ce o

f the

grou

nds

abou

t the

pla

nt?

1.Y

es4

31.2

07.

7870

.93

1332

.16

16.5

053

.21

00.

000.

000.

0017

31.1

315

.72

52.2

9

2.N

o15

63.1

626

.49

89.0

811

55.6

729

.57

78.9

81

100.

0010

0.00

100.

0027

59.5

837

.22

78.5

6

No

answ

er2

5.64

1.24

22.1

82

12.1

71.

8949

.91

00.

000.

000.

004

9.29

2.23

31.4

9

(Ski

p to

que

stio

n 4.

12)

(con

tinue

d)


D-15

Ta

ble

D-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.11

[If

4.9

is 2

(les

sor)

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

the

faci

lity

owne

ris

pro

perl

y m

aint

aini

ng th

e gr

ound

s?

1.Y

es6

15.8

05.

6736

.94

536

.58

11.4

971

.93

110

0.00

100.

0010

0.00

1223

.86

11.4

243

.25

2.N

o23

42.8

823

.83

64.3

17

49.0

018

.65

80.1

10

0.00

0.00

0.00

3044

.30

27.5

162

.50

Don

’t kn

ow1

1.48

0.19

10.5

40

0.00

0.00

0.00

00.

000.

000.

001

0.97

0.13

6.96

No

answ

er10

39.8

320

.44

63.0

44

14.4

23.

8241

.65

00.

000.

000.

0014

30.8

615

.63

51.8

2

4.12

For

leas

ed fa

cilit

ies,

who

ispr

imar

ily r

espo

nsib

le fo

r ge

nera

lm

aint

enan

ce a

nd s

anita

tion

of th

ebu

ildin

gs, f

ixtu

res,

and

oth

erph

ysic

al fa

cilit

ies

of th

e pl

ant?

1.Pl

ant m

anag

emen

t (le

ssee

)44

63.3

543

.38

79.6

039

95.6

388

.47

98.4

21

53.8

26.

5895

.07

8477

.23

63.3

986

.92

2.Fa

cilit

y ow

ner

(less

or) (

Skip

toqu

estio

n 4.

15)

1730

.72

16.1

050

.61

44.

371.

5811

.53

146

.18

4.93

93.4

222

19.5

110

.85

32.5

6

No

answ

er1

5.93

0.78

33.5

40

0.00

0.00

0.00

00.

000.

000.

001

3.26

0.43

20.7

5

4.13

[If

4.12

is 1

(les

see)

]Fo

r le

ased

faci

litie

s, a

re th

ere

wri

tten

proc

edur

es o

n ge

nera

l mai

nten

ance

and

sani

tatio

n of

the

build

ings

,fix

ture

s, a

nd o

ther

phy

sica

l fac

ilitie

sof

the

plan

t?

1.Y

es21

39.5

121

.46

60.9

725

61.5

740

.29

79.1

91

100.

0010

0.00

100.

0047

52.0

637

.84

65.9

6

2.N

o19

54.1

333

.43

73.4

912

36.7

119

.39

58.3

20

0.00

0.00

0.00

3144

.15

30.7

658

.45

No

answ

er4

6.36

2.21

16.9

42

1.71

0.43

6.55

00.

000.

000.

006

3.79

1.62

8.61

(con

tinue

d)


D-16

Ta

ble

D-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.14

[If

4.12

is 1

(les

see)

]Fo

r le

ased

faci

litie

s, a

re th

ere

wri

tten

proc

edur

es o

n th

e st

orag

e an

d us

eof

cle

anin

g an

d sa

nitiz

ing

mat

eria

ls?

1.Y

es18

33.3

516

.81

55.3

426

59.9

438

.32

78.2

81

100.

0010

0.00

100.

0045

48.4

134

.39

62.6

8

2.N

o22

61.0

239

.75

78.7

911

38.3

420

.27

60.3

40

0.00

0.00

0.00

3348

.13

34.1

862

.37

No

answ

er4

5.63

2.04

14.6

22

1.71

0.43

6.55

00.

000.

000.

006

3.46

1.56

7.52

(Ski

p to

que

stio

n 4.

17)

4.15

[If

4.12

is 2

(les

sor)

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

the

faci

lity

owne

ris

pro

perl

y m

aint

aini

ng th

ebu

ildin

gs, f

ixtu

res,

and

oth

erph

ysic

al fa

cilit

ies

of th

e pl

ant?

1.Y

es5

48.4

4—

—a

00.

00—

—a

110

0.00

——

a6

45.6

7—

—a

2.N

o9

26.3

9—

—a

410

0.00

——

a0

0.00

——

a13

32.5

7—

—a

Don

’t kn

ow0

0.00

——

a0

0.00

——

a0

0.00

——

a0

0.00

——

a

No

answ

er3

25.1

7—

—a

00.

00—

—a

00.

00—

—a

321

.76

——

a

4.16

[If

4.12

is 2

(les

sor)

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

the

clea

ning

and

sani

tizin

g m

ater

ials

use

d by

the

faci

lity

owne

r ar

e be

ing

prop

erly

stor

ed a

nd u

sed?

1.Y

es6

51.3

1—

—a

00.

00—

—a

110

0.00

——

a7

48.1

5—

—a

2.N

o8

23.5

2—

—a

410

0.00

——

a0

0.00

——

a12

30.0

9—

—a

Don

’t kn

ow0

0.00

——

a0

0.00

——

a0

0.00

——

a0

0.00

——

a

No

answ

er3

25.1

7—

—a

00.

00—

—a

00.

00—

—a

321

.76

——

a

(con

tinue

d)


D-17

Ta

ble

D-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.17

For

leas

ed fa

cilit

ies,

who

ispr

imar

ily r

espo

nsib

le fo

r pe

stco

ntro

l?

1.Pl

ant m

anag

emen

t (le

ssee

)43

63.4

243

.62

79.5

338

88.1

465

.12

96.7

31

53.8

26.

5895

.07

8274

.02

60.1

984

.29

2.Fa

cilit

y ow

ner

(less

or) (

Skip

toqu

estio

n 4.

19)

1729

.77

15.4

749

.56

511

.86

3.27

34.8

81

46.1

84.

9393

.42

2322

.25

12.7

735

.87

Not

app

licab

le1

0.88

0.12

6.25

00.

000.

000.

000

0.00

0.00

0.00

10.

480.

073.

45

No

answ

er1

5.93

0.78

33.5

40

0.00

0.00

0.00

00.

000.

000.

001

3.26

0.43

20.7

5

4.18

[If

4.17

is 1

(les

see)

]Fo

r le

ased

faci

litie

s, a

re th

ere

wri

tten

proc

edur

es o

n pe

st c

ontr

ol?

1.Y

es14

32.4

315

.72

55.2

631

89.3

576

.29

95.6

31

100.

0010

0.00

100.

0046

62.6

947

.96

75.4

0

2.N

o26

63.7

041

.49

81.2

86

9.72

3.75

22.9

50

0.00

0.00

0.00

3235

.01

22.5

249

.95

No

answ

er3

3.87

1.16

12.1

21

0.93

0.12

6.66

00.

000.

000.

004

2.30

0.84

6.13

(Ski

p to

que

stio

n 4.

20)

4.19

[If

4.17

is 2

(les

sor)

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

the

faci

lity

owne

ris

taki

ng p

rope

r pe

st c

ontr

olm

easu

res?

1.Y

es4

42.2

9—

—a

16.

91—

—a

110

0.00

——

a6

36.0

0—

—a

2.N

o9

44.1

8—

—a

493

.09

——

a0

0.00

——

a13

54.0

5—

—a

Don

’t kn

ow1

2.96

——

a0

0.00

——

a0

0.00

——

a1

2.18

——

a

No

answ

er3

10.5

7—

—a

00.

00—

—a

00.

00—

—a

37.

77—

—a

(con

tinue

d)


D-18

Ta

ble

D-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.20

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at p

roce

dure

s fo

rbu

ildin

gs a

nd fa

cilit

ies

mai

nten

ance

are

bein

g fo

llow

ed?

1.Y

es24

40.2

624

.33

58.5

530

61.6

242

.38

77.8

12

100.

0010

0.00

100.

0056

50.5

039

.61

61.3

5

2.N

o (S

kip

to S

ectio

n 5)

3446

.08

28.9

364

.21

1230

.89

15.5

452

.07

00.

000.

000.

0046

38.7

427

.06

51.8

8

Not

app

licab

le1

0.88

0.12

6.25

00.

000.

000.

000

0.00

0.00

0.00

10.

480.

073.

45

Don

’t kn

ow1

0.92

0.12

6.49

00.

000.

000.

000

0.00

0.00

0.00

10.

510.

073.

61

No

answ

er2

11.8

53.

0436

.55

17.

491.

0438

.42

00.

000.

000.

003

9.77

3.41

24.9

4

4.21

[If

4.20

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es12

68.4

150

.03

82.4

115

37.8

321

.07

58.1

12

100.

0010

0.00

100.

0029

53.1

938

.23

67.5

9

2.Y

es, f

or a

ll pr

oced

ures

617

.89

7.30

37.6

06

21.3

77.

4247

.97

00.

000.

000.

0012

19.1

79.

2935

.46

3.N

o4

9.10

3.28

22.7

97

31.4

113

.93

56.4

40

0.00

0.00

0.00

1120

.65

10.1

537

.47

No

answ

er2

4.60

1.07

17.7

22

9.39

2.25

31.8

20

0.00

0.00

0.00

47.

002.

3519

.05

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.b I

f 50%

or

mor

e of

the

plan

t’s fa

cilit

ies

are

owne

d, th

e re

spon

dent

com

plet

ed q

uest

ions

4.2

thro

ugh

4.7.

If 5

0% o

r m

ore

of th

e pl

ant’s

faci

litie

s ar

e le

ased

, the

resp

onde

nt c

ompl

eted

que

stio

ns 4

.8 th

roug

h 4.

21.


D-19

Ta

ble

D-5

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

5: E

qu

ipm

en

t

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

5.0

Is e

quip

men

t at t

his

plan

t or

site

used

to p

roce

ss r

aw m

ater

ials

, in-

proc

ess

mat

eria

ls, o

r fin

ishe

dpr

oduc

ts?

1.Y

es92

84.0

671

.38

91.7

711

097

.61

92.8

599

.23

1395

.51

73.5

399

.39

215

91.6

285

.53

95.2

8

2.N

o (S

kip

to S

ectio

n 6)

1815

.94

8.23

28.6

24

2.39

0.77

7.15

14.

490.

6126

.47

238.

384.

7214

.47

5.1

Are

ther

e w

ritte

n pr

oced

ures

on

the

clea

ning

, san

itizi

ng, a

ndm

aint

aini

ng o

f equ

ipm

ent a

ndut

ensi

ls?

1.Y

es57

60.5

045

.22

73.9

895

81.0

468

.32

89.4

413

100.

0010

0.00

100.

0016

573

.89

64.9

281

.23

2.N

o (S

kip

to q

uest

ion

5.4)

3539

.50

26.0

254

.78

1518

.96

10.5

631

.68

00.

000.

000.

0050

26.1

118

.77

35.0

8

5.2

[If

5.1

is Y

es]

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at th

ese

proc

edur

esar

e be

ing

follo

wed

?

1.Y

es45

73.5

252

.51

87.4

583

87.7

175

.57

94.2

812

93.1

563

.79

99.0

614

083

.48

73.7

790

.08

2.N

o (S

kip

to q

uest

ion

5.4)

1124

.93

11.3

846

.19

1011

.30

4.97

23.6

91

6.85

0.94

36.2

122

15.4

28.

9925

.17

No

answ

er1

1.55

0.21

10.6

32

0.99

0.24

4.06

00.

000.

000.

003

1.10

0.33

3.59

5.3

[If

5.2

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es20

40.1

224

.32

58.2

932

34.4

022

.60

48.5

24

30.7

711

.30

60.7

856

35.7

526

.13

46.6

8

2.Y

es, f

or a

ll pr

oced

ures

1639

.10

20.8

660

.99

3748

.75

34.9

762

.72

760

.67

31.8

583

.58

6046

.96

36.1

958

.02

3.N

o7

10.0

64.

6220

.55

1316

.22

8.60

28.4

81

8.57

1.14

43.2

221

13.8

28.

3721

.96

No

answ

er2

10.7

11.

8643

.15

10.

630.

094.

460

0.00

0.00

0.00

33.

480.

7115

.32

(con

tinue

d)


D-20

Ta

ble

D-5

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

5: E

qu

ipm

en

t (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

5.4

Doe

s th

is p

lant

val

idat

e th

ateq

uipm

ent,

inst

rum

ents

, and

cont

rols

are

inst

alle

d co

rrec

tly?

1.Y

es63

67.7

152

.41

79.9

670

56.2

544

.36

67.4

711

85.1

755

.40

96.3

714

462

.40

53.6

270

.44

2.N

o25

26.2

915

.30

41.3

437

40.2

429

.29

52.2

61

6.85

0.94

36.1

663

32.8

525

.07

41.7

1

No

answ

er4

6.00

1.45

21.6

93

3.50

1.13

10.3

61

7.98

1.08

40.8

58

4.74

1.99

10.9

0

5.5

Doe

s th

is p

lant

val

idat

e th

ateq

uipm

ent,

inst

rum

ents

, and

cont

rols

are

use

d co

rrec

tly?

1.Y

es68

67.4

251

.84

79.9

080

66.1

953

.65

76.8

011

85.1

755

.40

96.3

715

967

.72

59.0

175

.35

2.N

o22

27.8

216

.14

43.5

628

31.4

821

.15

44.0

31

6.85

0.94

36.1

651

28.6

721

.25

37.4

5

No

answ

er2

4.76

0.83

23.0

92

2.34

0.58

8.96

17.

981.

0840

.85

53.

611.

2310

.11

5.6

Doe

s th

is p

lant

val

idat

e th

eeq

uipm

ent u

sed

in q

ualit

y co

ntro

l?Q

ualit

y co

ntro

l equ

ipm

ent i

nclu

des

auto

mat

ic, m

echa

nica

l, el

ectr

onic

,an

d co

mpu

ter

equi

pmen

t, in

clud

ing

hard

war

e an

d so

ftwar

e.

1.Y

es55

62.9

847

.92

75.8

882

67.1

154

.22

77.8

610

77.2

047

.55

92.6

714

766

.02

56.7

774

.18

2.N

o28

24.2

214

.66

37.2

925

30.1

019

.67

43.0

92

14.8

33.

6344

.60

5526

.92

19.4

935

.92

No

answ

er9

12.8

05.

0928

.65

32.

790.

838.

981

7.98

1.08

40.8

513

7.06

3.39

14.1

5


D-21

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.1

Is th

ere

a un

it or

per

son

resp

onsi

ble

for

qual

ity c

ontr

ol?

1.Y

es85

74.4

560

.20

84.8

710

892

.39

79.8

697

.38

1291

.00

69.4

997

.82

205

84.5

276

.64

90.0

8

2.N

o (S

kip

to q

uest

ion

6.4)

1112

.12

5.24

25.5

94

6.85

2.11

20.0

41

4.51

0.61

26.5

816

9.02

4.71

16.5

9

Not

app

licab

le (S

kip

toqu

estio

n 6.

4)10

8.53

3.44

19.6

10

0.00

0.00

0.00

00.

000.

000.

0010

3.70

1.50

8.87

No

answ

er4

4.91

1.15

18.6

62

0.76

0.18

3.09

14.

490.

6126

.47

72.

760.

878.

40

6.2

[If

6.1

is Y

es]

Are

ther

e w

ritte

n pr

oced

ures

on

the

resp

onsi

bilit

ies

and

proc

edur

esre

quir

ed o

f the

qua

lity

cont

rol

unit/

pers

on?

1.Y

es48

64.5

349

.77

76.9

691

86.0

375

.54

92.4

712

100.

0010

0.00

100.

0015

178

.59

70.7

084

.81

2.N

o29

29.0

417

.62

43.9

214

11.1

55.

4721

.40

00.

000.

000.

0043

17.3

711

.65

25.0

8

No

answ

er8

6.44

3.10

12.8

73

2.82

0.81

9.37

00.

000.

000.

0011

4.04

2.11

7.62

(con

tinue

d)


D-22

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.3*

[If

6.1

is Y

es]

For

whi

ch o

f the

follo

win

g do

es th

equ

ality

con

trol

uni

t/per

son

have

resp

onsi

bilit

y an

d au

thor

ity?

1.A

ppro

val/r

ejec

tion

of c

lean

ing

and

mai

nten

ance

pro

cedu

res

6577

.50

62.8

787

.51

7364

.90

52.4

675

.60

1083

.25

51.4

395

.89

148

70.7

661

.79

78.3

6

2.A

ppro

val/r

ejec

tion

ofpr

oced

ures

, spe

cific

atio

ns,

cont

rols

, tes

ts, a

nd e

xam

inat

ions

for

puri

ty, q

ualit

y, a

ndco

mpo

sitio

n

6883

.20

69.8

291

.39

9589

.28

81.3

394

.09

1210

0.00

100.

0010

0.00

175

87.5

681

.10

92.0

3

3.A

ppro

val/r

ejec

tion

of r

awm

ater

ials

7076

.70

59.7

587

.95

9684

.69

72.6

492

.02

1191

.63

57.7

098

.87

177

82.0

272

.99

88.5

1

4.A

ppro

val/r

ejec

tion

of p

acka

ging

mat

eria

ls70

77.2

560

.44

88.2

984

71.5

758

.90

81.5

611

91.6

357

.70

98.8

716

574

.88

65.5

882

.34

5.A

ppro

val/r

ejec

tion

of la

belin

g70

80.3

564

.30

90.2

783

74.3

262

.43

83.4

49

74.8

844

.00

91.8

716

276

.66

67.8

683

.63

6.A

ppro

val/r

ejec

tion

of fi

nish

eddi

etar

y pr

oduc

ts67

83.5

172

.48

90.6

995

85.9

474

.87

92.6

212

100.

0010

0.00

100.

0017

485

.81

78.6

290

.86

7.O

ther

43.

211.

158.

644

2.75

0.92

7.97

216

.75

4.11

48.5

710

3.72

1.92

7.10

No

answ

er4

3.18

1.14

8.60

55.

292.

1012

.67

00.

000.

000.

009

4.18

2.05

8.34

(con

tinue

d)


D-23

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.4

Doe

s th

is p

lant

req

uire

sup

plie

rs to

prov

ide

a C

ertif

icat

e of

Ana

lysi

s?

1.Y

es, f

rom

som

e su

pplie

rs39

29.6

819

.28

42.7

129

20.0

512

.54

30.4

95

32.1

013

.20

59.5

273

24.8

618

.49

32.5

5

2.Y

es, f

rom

all

supp

liers

4245

.16

32.1

758

.84

7672

.18

60.7

581

.31

755

.79

29.9

478

.85

125

59.5

851

.21

67.4

3

3.N

o, d

o no

t req

uire

Cof

A fr

oman

y su

pplie

rs (S

kip

toqu

estio

n 6.

7)

1410

.53

4.93

21.0

83

1.11

0.35

3.45

00.

000.

000.

0017

5.14

2.60

9.92

4.D

o no

t rec

eive

ingr

edie

nts

(Ski

pto

que

stio

n 6.

7)6

6.40

2.00

18.6

23

4.76

1.24

16.5

61

7.62

1.03

39.4

710

5.63

2.48

12.2

7

Don

’t kn

ow2

1.06

0.26

4.23

00.

000.

000.

000

0.00

0.00

0.00

20.

460.

111.

84

No

answ

er7

7.16

2.48

18.9

63

1.90

0.51

6.88

14.

490.

6126

.47

114.

321.

899.

58

6.5

[If

6.4

is Y

es]

Doe

s th

is p

lant

ver

ify th

e re

liabi

lity

of th

e su

pplie

rs’ C

ertif

icat

e of

Ana

lysi

s?

1.Y

es46

66.6

551

.67

78.8

885

80.6

268

.80

88.7

010

87.4

360

.01

96.9

914

175

.62

67.1

482

.48

2.N

o (S

kip

to q

uest

ion

6.7)

3332

.33

20.2

547

.33

2019

.38

11.3

031

.20

212

.57

3.01

39.9

955

23.9

917

.16

32.4

8

No

answ

er2

1.02

0.26

3.93

00.

000.

000.

000

0.00

0.00

0.00

20.

390.

101.

52

(con

tinue

d)


D-24

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.6*

[If

6.5

is Y

es]

How

is r

elia

bilit

y of

the

supp

liers

’C

ertif

icat

e of

Ana

lysi

s ve

rifie

d?

1.C

ondu

ct o

n-si

te r

evie

w o

fsu

pplie

rs’ o

pera

tions

2057

.74

38.5

974

.81

3329

.92

20.8

240

.94

990

.08

52.3

298

.69

6243

.16

32.6

154

.37

2.Pe

rfor

m te

sts

in-h

ouse

to c

onfir

mre

sults

1220

.92

9.33

40.5

057

68.6

354

.57

79.9

310

100.

0010

0.00

100.

0079

54.4

243

.60

64.8

3

3.U

se o

ff-si

te la

bora

tory

to c

onfir

mre

sults

3274

.19

53.3

787

.84

6368

.50

53.7

980

.25

435

.91

13.1

467

.47

9968

.37

57.2

977

.70

4.R

equi

re s

uppl

iers

to c

ondu

ctte

sts

as p

art o

f sup

ply

spec

ifica

tions

1750

.37

30.6

469

.98

3342

.45

29.6

056

.40

435

.91

13.1

467

.47

5444

.72

34.4

255

.50

5.St

anda

rd r

efer

ence

mat

eria

ls16

30.4

315

.72

50.6

435

39.7

327

.17

53.8

03

25.9

97.

9558

.80

5435

.70

25.8

846

.90

6.O

ther

38.

131.

9628

.12

23.

720.

6518

.59

19.

921.

3147

.68

65.

602.

2513

.27

No

answ

er2

2.08

0.51

8.08

11.

530.

2110

.39

00.

000.

000.

003

1.62

0.45

5.63

6.7*

Doe

s th

is p

lant

con

duct

test

s on

any

raw

mat

eria

ls?

1.Y

es, i

n-ho

use

4531

.56

21.5

043

.70

7870

.16

58.2

479

.85

1073

.32

44.4

290

.43

133

53.5

545

.26

61.6

6

2.Y

es, o

ff-si

te48

45.3

232

.51

58.7

868

59.3

347

.23

70.4

04

29.4

011

.26

57.7

612

051

.67

43.0

860

.17

3.N

o (S

kip

to q

uest

ion

6.14

)23

21.4

712

.13

35.1

311

9.53

4.41

19.4

02

15.6

63.

5048

.70

3615

.04

9.73

22.5

2

Not

app

licab

le (S

kip

toqu

estio

n 6.

14)

76.

892.

3218

.74

00.

000.

000.

000

0.00

0.00

0.00

72.

991.

018.

55

No

answ

er5

5.72

1.59

18.5

54

2.39

0.77

7.15

14.

490.

6126

.47

103.

941.

629.

28

(con

tinue

d)


D-25

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.8

[If

6.7

is Y

es]

Wha

t per

cent

age

of r

aw m

ater

ials

are

sam

pled

and

test

ed?

(Pro

vide

aver

age

for

all r

aw m

ater

ials

.)

% o

f lot

s (m

ean

resp

onse

)71

58.4

944

.87

72.1

196

70.6

459

.91

81.3

711

93.2

083

.87

102.

5417

867

.48

59.4

375

.53

6.9*

[If

6.7

is Y

es]

Whi

ch o

f the

follo

win

g te

stin

gte

chni

ques

are

use

d to

con

firm

iden

tity

of in

gred

ient

s fo

r ra

wm

ater

ials

?

1.Ph

ysic

al61

76.0

857

.62

88.1

685

88.9

479

.76

94.2

510

90.4

653

.91

98.7

115

684

.30

75.5

290

.34

2.C

hem

ical

3559

.40

44.4

172

.82

7682

.51

72.8

889

.22

1110

0.00

100.

0010

0.00

122

74.9

667

.54

81.1

7

3.M

icro

biol

ogic

al30

53.8

839

.01

68.0

953

57.4

944

.55

69.4

87

61.8

331

.65

85.0

090

56.4

047

.06

65.3

0

4.V

isua

l (m

acro

scop

ic o

rm

icro

scop

ic)

5462

.88

45.4

977

.48

7378

.26

68.6

885

.53

761

.83

31.6

585

.00

134

71.7

362

.41

79.5

0

5.O

rgan

olep

tic34

33.6

621

.70

48.1

659

61.1

148

.15

72.6

75

46.3

620

.44

74.4

198

50.2

440

.72

59.7

4

6.N

o te

sts

are

cond

ucte

d to

conf

irm

iden

tity

of in

gred

ient

s1

5.29

0.72

29.9

31

0.52

0.07

3.71

00.

000.

000.

002

2.24

0.39

11.8

5

7.O

ther

58.

712.

4326

.73

84.

492.

049.

600

0.00

0.00

0.00

135.

802.

6212

.33

No

answ

er0

0.00

0.00

0.00

10.

370.

052.

620

0.00

0.00

0.00

10.

210.

031.

52

(con

tinue

d)


D-26

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.10

* [

If 6.

7 is

Yes

]W

hich

of t

he fo

llow

ing

test

ing

tech

niqu

es a

re u

sed

for

dete

ctin

gco

ntam

inat

ion

of r

aw m

ater

ials

?

1.Ph

ysic

al50

65.4

848

.49

79.2

668

68.3

856

.04

78.5

87

61.8

331

.65

85.0

012

566

.96

57.5

275

.22

2.C

hem

ical

3154

.24

39.3

168

.44

5149

.84

37.3

562

.36

980

.91

47.1

195

.28

9153

.13

43.8

162

.23

3.M

icro

biol

ogic

al44

67.0

451

.71

79.4

477

74.2

660

.62

84.3

97

61.8

331

.65

85.0

012

870

.94

61.3

478

.98

4.V

isua

l (m

acro

scop

ic o

rm

icro

scop

ic)

5363

.35

45.9

477

.86

7681

.50

72.3

488

.13

652

.28

24.6

278

.61

135

73.2

764

.00

80.8

6

5.O

rgan

olep

tic32

31.6

420

.08

46.0

245

49.6

837

.11

62.2

93

27.2

88.

8559

.16

8041

.85

32.6

751

.64

6.N

o te

sts

are

cond

ucte

d to

det

ect

cont

amin

atio

n1

5.29

0.72

29.9

31

0.55

0.08

3.87

19.

541.

2946

.09

32.

770.

6411

.23

7.O

ther

21.

610.

396.

424

2.10

0.79

5.43

00.

000.

000.

006

1.80

0.82

3.94

No

answ

er0

0.00

0.00

0.00

21.

660.

337.

920

0.00

0.00

0.00

20.

960.

194.

65

6.11

[If

6.7

is Y

es]

Doe

s th

is p

lant

con

duct

che

mic

alte

sts

to d

eter

min

e po

tenc

y of

raw

mat

eria

ls?

1.Y

es28

38.3

824

.01

55.1

171

75.8

663

.93

84.7

810

91.8

158

.94

98.8

710

962

.96

53.5

871

.46

2.N

o45

55.5

439

.45

70.5

526

22.4

813

.84

34.3

51

8.19

1.13

41.0

672

33.8

525

.87

42.8

7

No

answ

er2

6.08

1.06

28.1

72

1.66

0.33

7.92

00.

000.

000.

004

3.19

0.85

11.2

7

(con

tinue

d)


D-27

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.12

[If

6.7

is Y

es]

For

the

mos

t rec

ent f

isca

l yea

r,ap

prox

imat

ely

wha

t per

cent

age

ofra

w m

ater

ials

was

rej

ecte

d be

caus

eof

the

wro

ng id

entit

y,co

ntam

inat

ion,

or

pote

ncy?

% o

f lot

s (m

ean

resp

onse

)74

2.58

1.02

4.15

953.

842.

375.

3211

1.78

0.75

2.80

180

3.26

2.24

4.29

6.13

[If

6.12

> 0

]W

hat w

as th

e re

ason

(s) f

or th

ere

ject

ion?

(mea

n re

spon

se in

%)

1.M

icro

bial

con

tam

inat

ion

4128

.85

13.2

644

.43

7235

.41

24.6

946

.12

87.

870.

5915

.16

121

31.8

623

.51

40.2

0

2.Pe

stic

ide,

her

bici

de, f

ungi

cide

cont

amin

atio

n41

2.77

0.02

5.52

721.

040.

00b

2.29

83.

280.

00b

7.37

121

1.66

0.53

2.80

3.O

ther

che

mic

al c

onta

min

atio

n41

0.66

0.00

b1.

5772

3.75

0.37

7.13

825

.86

0.00

b52

.66

121

4.25

1.32

7.18

4.W

rong

ingr

edie

nt41

23.5

610

.28

36.8

272

14.6

88.

0521

.31

82.

100.

00b

4.62

121

16.4

010

.55

22.2

5

5.Su

bpot

ency

4127

.47

18.9

436

.00

7221

.95

11.4

532

.45

829

.66

9.05

50.2

612

123

.98

16.5

431

.43

6.Su

perp

oten

cy41

2.01

0.00

b5.

3072

1.37

0.00

b2.

918

2.62

0.04

5.21

121

1.63

0.26

2.99

7.A

flato

xin

or o

ther

toxi

n41

0.34

0.00

b1.

0272

1.23

0.00

b2.

858

0.00

0.00

0.00

121

0.90

0.00

b1.

98

8.O

ther

4114

.35

4.34

24.3

572

20.5

712

.49

28.6

68

28.6

10.

00b

58.2

212

119

.32

13.0

625

.58

(con

tinue

d)


D-28

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.14

Doe

s th

is p

lant

con

duct

test

s on

any

in-p

roce

ss m

ater

ials

and

/or

finis

hed

prod

ucts

?

1.Y

es61

55.8

142

.08

68.7

191

79.9

468

.05

88.1

710

73.3

244

.42

90.4

316

269

.11

60.6

576

.45

2.N

o (S

kip

to q

uest

ion

6.21

)37

31.6

920

.60

45.3

421

19.3

011

.16

31.2

82

15.6

63.

5048

.70

6024

.49

17.7

232

.81

Not

app

licab

le (S

kip

toqu

estio

n 6.

21)

87.

142.

5118

.65

00.

000.

000.

001

6.54

0.90

34.9

19

3.45

1.32

8.70

No

answ

er4

5.36

1.38

18.6

72

0.76

0.18

3.09

14.

490.

6126

.47

72.

960.

998.

53

6.15

[If

6.14

is Y

es]

Wha

t per

cent

age

of in

-pro

cess

mat

eria

ls a

nd/o

r fin

ishe

d pr

oduc

tsar

e sa

mpl

ed a

nd te

sted

?

In-p

roce

ss m

ater

ials

: %

of b

atch

es(m

ean

resp

onse

)60

48.7

631

.01

66.5

189

58.2

047

.44

68.9

710

91.6

875

.98

107.

3915

956

.76

47.4

966

.02

Fini

shed

pro

duct

s: %

of b

atch

es(m

ean

resp

onse

)60

50.1

932

.60

67.7

989

72.3

262

.79

81.8

610

89.6

169

.97

109.

2415

965

.46

56.5

474

.37

(con

tinue

d)


D-29

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.16

* [

If 6.

14 is

Yes

]W

hich

of t

he fo

llow

ing

test

ing

tech

niqu

es a

re u

sed

to c

onfir

mid

entit

y of

ingr

edie

nts

for

in-p

roce

ssm

ater

ials

and

/or

finis

hed

prod

ucts

?

1.Ph

ysic

al48

83.4

669

.34

91.8

561

71.5

660

.05

80.8

18

79.2

143

.95

94.8

811

776

.16

68.4

382

.49

2.C

hem

ical

2145

.50

28.8

163

.27

6674

.47

62.0

483

.89

1010

0.00

100.

0010

0.00

9765

.73

56.0

174

.29

3.M

icro

biol

ogic

al19

36.0

120

.40

55.2

735

40.1

628

.04

53.6

26

58.4

227

.81

83.6

760

39.7

230

.13

50.1

7

4.V

isua

l (m

acro

scop

ic o

rm

icro

scop

ic)

3853

.17

35.5

570

.04

6271

.16

60.1

880

.12

658

.42

27.8

183

.67

106

64.1

453

.86

73.2

7

5.O

rgan

olep

tic25

30.6

118

.01

46.9

947

57.5

044

.99

69.1

24

41.5

816

.33

72.1

976

47.1

837

.13

57.4

7

6.N

o te

sts

are

cond

ucte

d to

conf

irm

iden

tity

of in

gred

ient

s1

0.93

0.13

6.52

31.

560.

504.

730

0.00

0.00

0.00

41.

250.

473.

28

7.O

ther

712

.63

4.28

31.8

74

3.19

1.07

9.13

110

.39

1.39

48.8

012

6.90

3.17

14.3

9

No

answ

er1

0.93

0.13

6.52

33.

401.

0010

.89

00.

000.

000.

004

2.35

0.80

6.68

(con

tinue

d)


D-30

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.17

* [

If 6.

14 is

Yes

]W

hich

of t

he fo

llow

ing

test

ing

tech

niqu

es a

re u

sed

for

dete

ctin

gco

ntam

inat

ion

of in

-pro

cess

mat

eria

ls a

nd/o

r fin

ishe

d pr

oduc

ts?

1.Ph

ysic

al40

68.6

150

.80

82.2

347

49.9

337

.09

62.7

87

68.8

235

.66

89.7

894

57.5

447

.48

67.0

0

2.C

hem

ical

2144

.06

27.5

162

.05

4038

.13

26.5

751

.20

879

.21

43.9

594

.88

6942

.50

32.8

952

.71

3.M

icro

biol

ogic

al33

62.1

745

.41

76.4

666

75.0

762

.71

84.3

67

68.8

235

.66

89.7

810

670

.20

60.8

378

.13

4.V

isua

l (m

acro

scop

ic o

rm

icro

scop

ic)

3757

.42

38.8

974

.08

5564

.97

52.4

275

.75

658

.42

27.8

183

.67

9861

.96

51.7

271

.23

5.O

rgan

olep

tic24

29.2

016

.89

45.5

636

47.2

735

.10

59.7

92

20.7

95.

1256

.05

6239

.46

29.8

949

.91

6.N

o te

sts

are

cond

ucte

d to

det

ect

cont

amin

atio

n1

0.93

0.13

6.52

54.

641.

7611

.69

110

.39

1.39

48.8

07

3.66

1.64

7.97

7.O

ther

44.

001.

3910

.97

44.

011.

3711

.18

110

.39

1.39

48.8

09

4.36

2.12

8.75

No

answ

er2

1.90

0.46

7.56

33.

401.

0010

.89

00.

000.

000.

005

2.69

1.01

6.92

6.18

[If

6.14

is Y

es]

Doe

s th

is p

lant

con

duct

che

mic

alte

sts

to d

eter

min

e po

tenc

y of

in-

proc

ess

mat

eria

ls a

nd/o

r fin

ishe

dpr

oduc

ts?

1.Y

es25

49.5

632

.38

66.8

570

82.4

473

.10

89.0

310

100.

0010

0.00

100.

0010

571

.88

62.8

579

.44

2.N

o35

49.5

132

.33

66.8

018

14.1

68.

5022

.64

00.

000.

000.

0053

25.7

718

.52

34.6

5

No

answ

er1

0.93

0.13

6.52

33.

401.

0010

.89

00.

000.

000.

004

2.35

0.80

6.68

(con

tinue

d)


D-31

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.19

[If

6.14

is Y

es]

For

the

mos

t rec

ent f

isca

l yea

r,ap

prox

imat

ely

wha

t per

cent

age

ofin

-pro

cess

mat

eria

ls a

nd/o

r fin

ishe

dpr

oduc

ts w

as r

ejec

ted

beca

use

ofth

e w

rong

iden

tity,

con

tam

inat

ion,

or p

oten

cy?

In-p

roce

ss m

ater

ials

: %

of

batc

hes

(mea

n re

spon

se)

442.

07c

0.00

b4.

9071

1.88

0.63

3.14

102.

820.

794.

8412

52.

010.

823.

20

Fini

shed

pro

duct

s: %

of b

atch

es(m

ean

resp

onse

)49

2.23

c0.

00b

4.94

804.

851.

148.

569

3.72

1.35

6.10

138

3.95

1.48

6.42

6.20

[If

6.19

> 0

]W

hat w

as th

e re

ason

(s) f

or th

ere

ject

ion?

In-P

roce

ss M

ater

ials

(mea

nre

spon

ses

in %

)

1.M

icro

bial

con

tam

inat

ion

2011

.85

0.00

b25

.73

3728

.65

9.87

47.4

27

5.80

0.44

11.1

664

21.5

59.

2533

.86

2.Pe

stic

ide,

her

bici

de, f

ungi

cide

cont

amin

atio

n20

0.00

0.00

0.00

370.

080.

00b

0.25

70.

000.

000.

0064

0.05

0.00

b0.

15

3.O

ther

che

mic

al c

onta

min

atio

n20

3.96

0.00

b11

.88

375.

220.

00b

11.4

87

9.16

0.00

b23

.46

645.

330.

829.

85

4.W

rong

ingr

edie

nt20

18.1

30.

8035

.47

3711

.84

1.53

22.1

57

0.91

0.00

b2.

3264

12.2

93.

4621

.11

5.Su

bpot

ency

2015

.69

0.00

b31

.48

3714

.60

6.23

22.9

67

61.4

832

.07

90.8

864

20.2

112

.06

28.3

5

6.Su

perp

oten

cy20

0.00

0.00

0.00

374.

310.

677.

957

1.51

0.00

b3.

7764

2.84

0.68

4.99

7.Fo

rmul

atio

n w

ith m

issi

ngin

gred

ient

206.

640.

00b

15.5

837

10.1

62.

6817

.63

76.

190.

00b

17.6

264

8.77

3.71

13.8

2

8.A

flato

xin

or o

ther

toxi

n20

1.80

0.00

b5.

5037

0.00

0.00

0.00

70.

000.

000.

0064

0.48

0.00

b1.

45

9.O

ther

2041

.92

9.87

73.9

837

25.1

512

.00

38.3

07

14.9

50.

00b

40.1

064

28.4

917

.44

39.5

4

(con

tinue

d)


D-32

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.20

(co

ntin

ued)

Fini

shed

Pro

duct

s (m

ean

resp

onse

sin

%)

1.M

icro

bial

con

tam

inat

ion

2226

.32

8.63

44.0

148

16.6

85.

3328

.02

84.

090.

00b

8.31

7817

.83

9.26

26.3

9

2.Pe

stic

ide,

her

bici

de, f

ungi

cide

cont

amin

atio

n22

0.71

0.00

b2.

1748

0.00

0.00

0.00

81.

970.

00b

5.69

780.

350.

00b

0.85

3.O

ther

che

mic

al c

onta

min

atio

n22

1.42

0.00

b3.

4248

2.47

0.00

b6.

248

15.8

60.

00b

34.2

178

3.46

0.31

6.60

4.W

rong

ingr

edie

nt22

9.53

0.00

b20

.21

4815

.11

4.69

25.5

48

1.97

0.00

b5.

6978

12.5

65.

3719

.75

5.Su

bpot

ency

2217

.41

3.88

30.9

548

23.3

411

.76

34.9

18

39.7

610

.37

69.1

578

23.4

313

.51

33.3

6

6.Su

perp

oten

cy22

0.00

0.00

0.00

485.

430.

5710

.30

81.

440.

00b

4.17

783.

760.

527.

00

7.Fo

rmul

atio

n w

ith m

issi

ngin

gred

ient

220.

870.

00b

2.60

483.

080.

495.

678

1.31

0.00

b3.

7978

2.39

0.48

4.30

8.A

flato

xin

or o

ther

toxi

n22

0.00

0.00

0.00

480.

000.

000.

008

0.00

0.00

0.00

780.

000.

000.

00

9.O

ther

2243

.73

20.6

366

.83

4833

.89

20.1

347

.65

833

.59

5.43

61.7

578

36.2

224

.97

47.4

8

(con

tinue

d)


D-33

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.21

* W

hich

of t

he fo

llow

ing

test

ing

met

hods

are

gen

eral

ly u

sed

for

test

ing

of r

aw m

ater

ials

, in-

proc

ess

mat

eria

ls, o

r fin

ishe

d pr

oduc

ts?

1.A

ssoc

iatio

n of

Ana

lytic

alC

hem

ists

(AO

AC

)28

25.2

515

.29

38.7

467

58.8

046

.73

69.9

03

21.7

87.

0350

.64

9842

.28

34.0

750

.94

2.U

.S. P

harm

acop

eia

(USP

)27

33.6

121

.61

48.1

976

72.0

761

.19

80.8

610

73.3

244

.42

90.4

311

355

.43

47.3

463

.24

3.Fo

od C

hem

ical

CO

DEX

(FC

C)

1112

.59

5.83

25.1

243

45.6

034

.47

57.1

97

49.3

724

.71

74.3

561

31.4

623

.94

40.0

9

4.A

mer

ican

Che

mic

al S

ocie

ty(A

CS)

64.

021.

669.

4122

20.7

912

.66

32.2

10

0.00

0.00

0.00

2812

.41

7.90

18.9

8

5.In

-hou

se m

etho

ds49

40.3

328

.34

53.6

063

57.3

745

.38

68.5

68

58.0

831

.45

80.7

112

050

.01

41.5

258

.49

6.O

ther

2720

.12

12.1

331

.48

2418

.92

11.4

029

.74

17.

621.

0339

.47

5218

.85

13.3

525

.93

7.N

o te

stin

g co

nduc

ted

(Ski

p to

que

stio

n 6.

24)

1614

.72

7.26

27.5

610

8.12

3.44

17.9

72

15.6

63.

5048

.70

2811

.38

6.83

18.3

6

Don

’t kn

ow0

0.00

0.00

0.00

12.

440.

3415

.37

00.

000.

000.

001

1.25

0.17

8.41

No

answ

er8

7.73

2.86

19.2

22

0.76

0.18

3.09

14.

490.

6126

.47

113.

981.

709.

08

6.22

[If

6.2

is 1

-6]

Doe

s yo

ur te

stin

g po

licy

spec

ify th

eus

e of

sta

ndar

d re

fere

nce

mat

eria

ls?

1.Y

es47

48.9

034

.59

63.3

978

72.4

559

.72

82.3

511

94.6

869

.66

99.2

813

663

.72

54.4

372

.08

2.N

o (S

kip

to q

uest

ion

6.24

)34

36.6

423

.83

51.6

718

18.0

110

.24

29.7

40

0.00

0.00

0.00

5224

.90

17.6

933

.85

Don

’t kn

ow2

1.28

0.31

5.09

00.

000.

000.

000

0.00

0.00

0.00

20.

530.

132.

14

No

answ

er11

13.1

85.

7127

.56

89.

534.

0720

.76

15.

320.

7230

.34

2010

.85

6.07

18.6

4

(con

tinue

d)


D-34

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.23

* [

If 6.

22 is

Yes

]W

hat i

s th

e so

urce

of t

he s

tand

ard

refe

renc

e m

ater

ials

?

1.C

ompe

ndia

l ref

eren

ce s

tand

ard

1851

.40

32.0

670

.32

6186

.26

77.4

491

.99

1090

.46

53.6

598

.73

8975

.39

66.5

682

.50

2.In

-hou

se p

rim

ary

refe

renc

em

ater

ials

2339

.05

22.3

058

.85

4053

.61

39.8

566

.84

1090

.46

53.6

598

.73

7351

.67

40.5

362

.66

3.In

-hou

se w

orki

ng r

efer

ence

mat

eria

ls22

30.8

018

.86

46.0

239

50.6

836

.40

64.8

410

90.4

653

.65

98.7

371

47.2

536

.57

58.1

9

4.O

ther

57.

693.

0917

.87

77.

193.

1315

.67

00.

000.

000.

0012

6.82

3.70

12.2

2

No

answ

er2

9.60

1.65

40.1

42

2.41

0.52

10.4

80

0.00

0.00

0.00

44.

541.

2315

.36

6.24

Doe

s yo

ur p

lant

hol

dre

pres

enta

tive

rese

rve

sam

ples

of

each

bat

ch m

anuf

actu

red?

1.Y

es73

64.9

850

.98

76.8

096

83.6

772

.25

90.9

710

72.2

442

.95

89.9

917

974

.95

66.6

481

.75

2.N

o (S

kip

to q

uest

ion

6.26

)24

21.7

312

.39

35.2

812

12.3

25.

9023

.96

215

.66

3.50

48.7

038

16.5

810

.90

24.4

2

Not

app

licab

le (S

kip

to q

uest

ion

6.26

)8

7.41

2.67

18.9

50

0.00

0.00

0.00

00.

000.

000.

008

3.22

1.16

8.61

No

answ

er5

5.88

1.68

18.5

86

4.01

1.62

9.59

212

.11

2.81

39.6

713

5.25

2.53

10.5

5

(con

tinue

d)


D-35

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.25

[If

6.24

is Y

es]

How

long

do

you

hold

repr

esen

tativ

e re

serv

e sa

mpl

es?

1.__

__ y

ear(

s) a

fter

expi

ratio

n da

te21

26.1

814

.54

42.5

039

46.0

933

.67

59.0

25

52.7

523

.96

79.8

265

38.9

329

.68

49.0

5

2.__

__ y

ear(

s) fr

om d

ate

ofm

anuf

actu

re39

58.7

842

.20

73.5

944

40.6

329

.35

53.0

04

38.2

014

.42

69.4

087

47.3

437

.72

57.1

7

3.O

ther

1113

.44

5.58

28.9

810

7.81

3.88

15.1

00

0.00

0.00

0.00

219.

535.

4116

.27

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

9.05

1.24

44.0

11

0.46

0.06

3.26

No

answ

er2

1.60

0.39

6.27

35.

471.

3619

.49

00.

000.

000.

005

3.73

1.13

11.6

7

Mea

n ye

ars

afte

r ex

pira

tion

date

212.

791.

584.

0039

1.91

1.44

2.38

51.

001.

001.

0065

2.07

1.56

2.58

Mea

n ye

ars

from

dat

e of

man

ufac

ture

394.

523.

875.

1744

4.11

3.47

4.75

44.

722.

726.

7387

4.33

3.85

4.81

6.26

Are

ther

e w

ritte

n pr

oced

ures

for

labo

rato

ry o

pera

tions

?

1.Y

es39

30.1

720

.15

42.5

174

64.4

952

.21

75.1

19

65.7

037

.75

85.8

212

249

.64

41.7

257

.57

2.N

o (S

kip

to q

uest

ion

6.31

)20

10.5

16.

7715

.95

1014

.69

7.26

27.4

51

4.51

0.61

26.5

831

12.3

47.

6419

.31

3.D

o no

t hav

e la

bora

tory

oper

atio

ns (S

kip

to S

ectio

n 7)

4653

.45

40.6

365

.83

2518

.00

10.8

228

.44

111

.15

1.56

49.7

472

33.0

425

.45

41.6

3

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

6.54

0.90

34.9

11

0.34

0.05

2.44

No

answ

er5

5.88

1.68

18.5

85

2.83

1.04

7.48

212

.11

2.81

39.6

712

4.64

2.12

9.86

(con

tinue

d)


D-36

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.27

[If

6.26

is Y

es]

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at th

ese

proc

edur

esar

e be

ing

follo

wed

?

1.Y

es32

85.9

171

.54

93.6

768

90.4

479

.85

95.7

69

100.

0010

0.00

100.

0010

989

.91

82.5

994

.36

2.N

o (S

kip

to q

uest

ion

6.29

)7

14.0

96.

3328

.46

46.

022.

1515

.76

00.

000.

000.

0011

7.73

4.06

14.2

4

No

answ

er0

0.00

0.00

0.00

23.

540.

8713

.29

00.

000.

000.

002

2.36

0.58

9.04

6.28

[If

6.27

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es14

47.6

324

.89

71.3

932

42.8

128

.87

57.9

92

23.2

05.

6760

.31

4842

.51

31.0

054

.89

2.Y

es, f

or a

ll pr

oced

ures

1444

.17

22.1

168

.80

3048

.64

34.1

163

.41

776

.80

39.6

994

.33

5149

.69

37.7

461

.67

3.N

o4

8.20

2.85

21.3

76

8.55

3.60

18.9

70

0.00

0.00

0.00

107.

803.

9414

.84

(con

tinue

d)


D-37

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.29

* [

If 6.

26 is

Yes

]D

o yo

ur w

ritte

n pr

oced

ures

for

labo

rato

ry o

pera

tions

incl

ude

any

ofth

e fo

llow

ing?

1.Sa

mpl

e se

lect

ion,

met

hod

desc

ript

ion,

val

idat

ion

ofm

etho

dolo

gy a

nd r

esul

ts,

acce

ptan

ce/r

ejec

tion

crite

ria,

and

use

of te

st r

esul

ts

3186

.53

73.7

893

.62

6888

.72

72.9

695

.82

910

0.00

100.

0010

0.00

108

88.9

378

.66

94.5

9

2.M

etho

ds fo

r de

term

inin

gin

gred

ient

iden

tity

and

for

dete

ctin

g ad

ulte

ratio

n

2572

.53

55.4

584

.85

5878

.80

64.2

088

.51

910

0.00

100.

0010

0.00

9278

.62

68.2

686

.28

3.Te

sts

to a

sses

s th

e st

abili

tych

arac

teri

stic

s of

pro

duct

s in

dete

rmin

ing

appr

opri

ate

stor

age

cond

ition

s an

d ex

pira

tion

datin

g(in

clud

e te

stin

g co

nduc

ted

atco

rpor

ate

head

quar

ters

)

1956

.90

38.1

473

.88

4358

.58

43.6

472

.09

910

0.00

100.

0010

0.00

7161

.01

49.3

271

.56

4.Pr

oced

ures

for

hand

ling

and

filin

g te

st r

ecor

ds24

72.6

156

.34

84.4

853

73.1

658

.63

83.9

89

100.

0010

0.00

100.

0086

74.8

864

.37

83.1

0

No

answ

er2

3.44

0.83

13.2

31

1.77

0.24

11.8

90

0.00

0.00

0.00

32.

090.

587.

22

(con

tinue

d)


D-38

Ta

ble

D-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.30

[If

6.26

is Y

es]

How

long

are

rec

ords

for

labo

rato

ryop

erat

ions

ret

aine

d?

1.__

_ ye

ar(s

) afte

r ex

pira

tion

date

928

.58

11.9

354

.18

2536

.69

23.7

551

.90

446

.40

18.3

076

.99

3835

.23

24.9

047

.15

2.__

_ ye

ar(s

) fro

m d

ate

ofm

anuf

actu

re20

52.9

931

.53

73.4

131

40.1

527

.16

54.6

85

53.6

023

.01

81.7

056

44.4

733

.56

55.9

4

3.O

ther

814

.99

7.01

29.2

017

21.3

911

.69

35.8

50

0.00

0.00

0.00

2518

.21

11.0

428

.55

No

answ

er2

3.44

0.83

13.2

31

1.77

0.24

11.8

90

0.00

0.00

0.00

32.

090.

587.

22

Mea

n ye

ars

afte

r ex

pira

tion

date

93.

51—

—a

251.

80—

—a

43.

00—

—a

382.

28—

—a

Mea

n ye

ars

from

dat

e of

man

ufac

ture

204.

893.

795.

9931

4.67

3.61

5.73

56.

085.

276.

8956

4.86

4.14

5.57

6.31

[If

6.26

is 1

or

2]D

oes

this

pla

nt v

erify

and

kee

pre

cord

s th

at la

bora

tory

equ

ipm

ent i

sca

libra

ted

corr

ectly

?

1.Y

es36

69.3

955

.82

80.2

772

76.7

362

.20

86.8

59

93.5

864

.78

99.1

411

775

.64

65.4

183

.60

2.N

o20

26.5

216

.69

39.4

011

21.8

312

.03

36.3

11

6.42

0.86

35.2

232

22.2

514

.60

32.3

9

Don

’t kn

ow1

1.28

0.17

8.84

00.

000.

000.

000

0.00

0.00

0.00

10.

360.

052.

59

No

answ

er2

2.81

0.73

10.2

51

1.44

0.20

9.77

00.

000.

000.

003

1.75

0.50

5.86

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.b E

stim

ated

con

fiden

ce in

terv

al fo

r lo

wer

bou

nd w

as le

ss th

an z

ero

so w

e tr

unca

ted

the

inte

rval

.c O

ne r

espo

nden

t in

the

very

sm

all c

ateg

ory

ente

red

100%

for

ques

tion

6.19

for

both

in-p

roce

ss m

ater

ials

and

fini

shed

pro

duct

s. T

he m

eans

exc

ludi

ng th

is r

espo

nse

are

0.66

for

in-p

roce

ss m

ater

ials

and

0.8

9 fo

r fin

ishe

d pr

oduc

ts fo

r ve

ry s

mal

l res

pond

ents

and

1.5

5 fo

r in

-pro

cess

mat

eria

ls a

nd 3

.54

for

finis

hed

prod

ucts

for

all

resp

onde

nts.

Thi

s re

spon

dent

did

not

ans

wer

que

stio

n 6.

20.

d Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

of m

atri

x co

nfor

mab

ility

err

or.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


D-39

Ta

ble

D-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.1

Are

ther

e w

ritte

n pr

oced

ures

for

rece

ipt o

f die

tary

sup

plem

ent

ingr

edie

nts?

1.Y

es56

52.6

839

.22

65.7

786

81.1

471

.24

88.1

910

75.7

648

.32

91.2

615

268

.49

60.2

175

.75

2.N

o (S

kip

to q

uest

ion

7.6)

2321

.43

12.1

035

.08

136.

383.

4811

.40

14.

510.

6126

.58

3712

.82

8.17

19.5

5

3.D

o no

t rec

eive

die

tary

supp

lem

ent i

ngre

dien

ts (S

kip

toqu

estio

n 7.

6)

2519

.24

10.9

931

.50

1210

.58

5.13

20.5

62

15.2

43.

7745

.23

3914

.59

9.59

21.5

7

No

answ

er6

6.65

2.14

18.7

93

1.90

0.51

6.88

14.

490.

6126

.47

104.

101.

729.

43

7.2

[If

7.1

is Y

es]

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at th

ese

proc

edur

esar

e be

ing

follo

wed

?

1.Y

es45

77.2

456

.71

89.7

975

86.0

873

.69

93.1

710

100.

0010

0.00

100.

0013

083

.93

74.0

390

.54

2.N

o (S

kip

to q

uest

ion

7.4)

1122

.76

10.2

143

.29

1012

.52

5.82

24.8

70

0.00

0.00

0.00

2115

.21

8.77

25.0

8

No

answ

er0

0.00

0.00

0.00

11.

410.

199.

570

0.00

0.00

0.00

10.

850.

125.

94

7.3

[If

7.2

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es24

43.2

927

.45

60.6

235

45.4

231

.72

59.8

62

24.7

76.

1862

.21

6143

.34

32.3

555

.03

2.Y

es, f

or a

ll pr

oced

ures

1338

.98

20.9

860

.58

2737

.65

24.4

652

.96

765

.17

31.5

188

.38

4739

.96

29.1

451

.87

3.N

o7

9.17

4.18

18.9

313

16.9

39.

1729

.15

110

.06

1.33

48.1

921

14.0

78.

6222

.12

No

answ

er1

8.57

1.17

42.6

20

0.00

0.00

0.00

00.

000.

000.

001

2.63

0.35

17.1

4

(con

tinue

d)


D-40

Ta

ble

D-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.4*

[If

7.1

is Y

es]

Do

your

wri

tten

proc

edur

es fo

rre

ceip

t of d

ieta

ry s

uppl

emen

tin

gred

ient

s in

clud

e an

y of

the

follo

win

g?

1.W

ritte

n ac

cept

ance

cri

teri

a fo

rdi

etar

y su

pple

men

t ing

redi

ents

deve

lope

d by

a c

ompe

tent

indi

vidu

al

3757

.67

38.6

974

.62

6879

.36

65.7

688

.50

1010

0.00

100.

0010

0.00

115

73.3

162

.59

81.8

5

2.C

ertif

icat

e of

Ana

lysi

ssp

ecifi

catio

ns43

86.8

277

.78

92.5

480

95.4

288

.71

98.2

210

100.

0010

0.00

100.

0013

392

.82

88.6

095

.55

3.R

epre

sent

ativ

e sa

mpl

e an

dau

then

ticat

ed p

lant

ref

eren

cehe

ld in

an

envi

ronm

enta

llyap

prop

riat

e re

posi

tory

for

each

rece

ivin

g an

d pr

oduc

tion

lot/b

atch

2341

.65

24.7

360

.79

5565

.97

52.0

977

.57

765

.17

31.6

188

.34

8557

.80

47.0

167

.89

4.R

ecor

ds li

nkin

g th

e C

ertif

icat

e of

Ana

lysi

s to

the

iden

tity

of th

eun

proc

esse

d ra

w m

ater

ial a

nd to

the

finis

hed

prod

uct

4283

.40

71.8

690

.81

6577

.75

64.2

687

.17

769

.82

36.5

990

.27

114

79.1

870

.06

86.0

7

5.R

ecor

ds to

trac

e an

d ve

rify

com

plia

nce

with

law

s on

har

vest

of w

ildcr

afte

d bo

tani

cals

1010

.07

5.37

18.0

89

11.0

94.

5224

.74

00.

000.

000.

0019

10.1

15.

3518

.28

6.A

udit

reco

rds

conc

erni

ng th

ere

liabi

lity

of s

uppl

ier

Cer

tific

ate

of A

naly

sis

1229

.48

14.8

450

.06

2935

.83

23.6

450

.16

875

.23

37.9

293

.79

4935

.99

26.3

946

.86

7.R

ecor

ds fo

r so

urce

of a

nim

alde

rive

d m

ater

ials

or

prod

ucts

617

.75

6.53

40.0

017

21.7

512

.49

35.1

20

0.00

0.00

0.00

2319

.15

11.8

129

.53

(con

tinue

d)


D-41

Ta

ble

D-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.4

[C

ontin

ued]

8.R

ecor

ds fo

r fis

h an

d fis

hery

dem

onst

ratin

g th

at F

DA

fish

and

fishe

ry p

rodu

cts

HA

CC

Pre

gula

tions

are

follo

wed

11.

030.

147.

181

0.57

0.08

4.03

18.

631.

1842

.85

31.

190.

383.

66

9.R

ecor

ds fo

r ra

w m

ater

ials

toas

sure

seg

rega

tion

of r

aw, i

n-pr

oces

s, a

nd fi

nish

ed p

rodu

ctan

d pr

otec

tion

agai

nst

adul

tera

tion

2644

.76

27.7

663

.09

4655

.85

42.1

668

.70

765

.17

31.6

188

.34

7952

.68

42.0

063

.13

No

answ

er0

0.00

0.00

0.00

11.

410.

199.

570

0.00

0.00

0.00

10.

850.

125.

94

7.5

[If

7.1

is Y

es]

How

long

are

rec

ords

on

rece

ipt o

fdi

etar

y su

pple

men

t ing

redi

ents

reta

ined

?

1.__

___

year

(s) a

fter

expi

ratio

nda

te14

22.8

611

.20

41.0

529

33.5

622

.00

47.5

13

30.1

89.

7363

.41

4629

.79

21.1

540

.16

2.__

___

year

(s) f

rom

dat

e of

man

ufac

ture

2855

.72

37.4

072

.60

3031

.15

20.6

144

.09

545

.05

18.6

274

.60

6340

.17

30.5

350

.62

3.O

ther

99.

294.

6117

.86

2633

.88

22.1

448

.01

224

.77

6.21

62.0

837

25.1

416

.97

35.5

5

Don

’t kn

ow2

7.60

1.32

33.6

40

0.00

0.00

0.00

00.

000.

000.

002

2.54

0.44

13.4

5

No

answ

er3

4.53

1.26

14.9

91

1.41

0.19

9.57

00.

000.

000.

004

2.37

0.81

6.74

Mea

n ye

ars

afte

r ex

pira

tion

date

143.

17—

—a

291.

94—

—a

33.

00—

—a

462.

31—

—a

Mea

n ye

ars

from

dat

e of

man

ufac

ture

284.

07—

—a

304.

79—

—a

56.

50—

—a

634.

57—

—a

(con

tinue

d)


D-42

Ta

ble

D-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.6

Are

ther

e w

ritte

n pr

oced

ures

for

prod

uctio

n pr

oces

ses?

1.Y

es65

55.5

441

.78

68.5

094

80.3

968

.23

88.6

712

91.0

069

.49

97.8

217

170

.15

61.6

777

.44

2.N

o (S

kip

to q

uest

ion

7.11

)14

7.27

4.31

12.0

09

8.07

3.37

18.0

81

4.51

0.61

26.5

824

7.53

4.43

12.5

3

3.N

o pr

oduc

tion

proc

esse

sco

nduc

ted

(Ski

p to

Sec

tion

8)24

30.0

118

.43

44.8

77

9.15

3.58

21.5

00

0.00

0.00

0.00

3117

.74

11.5

826

.19

No

answ

er7

7.19

2.50

18.9

84

2.39

0.77

7.15

14.

490.

6126

.47

124.

582.

089.

78

7.7

[If

7.6

is Y

es]

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at th

ese

proc

edur

esar

e be

ing

follo

wed

?

1.Y

es55

90.4

982

.95

94.9

092

98.0

191

.27

99.5

712

100.

0010

0.00

100.

0015

995

.56

92.1

397

.53

2.N

o (S

kip

to q

uest

ion

7.9)

87.

603.

7614

.74

21.

990.

438.

730

0.00

0.00

0.00

103.

791.

967.

20

No

answ

er2

1.91

0.46

7.58

00.

000.

000.

000

0.00

0.00

0.00

20.

660.

162.

63

7.8

[If

7.7

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es23

45.6

327

.92

64.5

245

45.6

333

.00

58.8

42

20.6

25.

1355

.54

7043

.85

33.9

254

.29

2.Y

es, f

or a

ll pr

oced

ures

2243

.20

25.9

262

.30

3540

.83

28.7

954

.08

971

.00

38.8

290

.43

6643

.75

34.1

453

.86

3.N

o10

11.1

75.

7620

.57

1213

.54

7.12

24.2

31

8.37

1.12

42.4

623

12.4

07.

8019

.14

(con

tinue

d)


D-43

Ta

ble

D-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.9*

[If

7.6

is Y

es]

Do

your

wri

tten

proc

edur

es fo

rpr

oduc

tion

proc

esse

s in

clud

e an

y of

the

follo

win

g?

1.M

aste

r pr

oduc

tion

and

cont

rol

reco

rds

4466

.83

48.5

481

.15

8594

.54

88.8

697

.40

1210

0.00

100.

0010

0.00

141

85.3

877

.18

90.9

8

2.B

atch

pro

duct

ion

and

cont

rol

reco

rds

5988

.93

69.1

796

.64

9197

.99

93.7

199

.38

1210

0.00

100.

0010

0.00

162

95.0

187

.60

98.0

9

3.Eq

uipm

ent u

se a

nd c

lean

ing

reco

rds,

incl

udin

g da

tes

of u

sean

d pr

oduc

t and

lot n

umbe

r of

each

bat

ch p

roce

ssed

4472

.20

55.9

084

.18

8083

.27

70.9

091

.05

1191

.63

57.5

998

.88

135

80.0

371

.14

86.6

9

4.R

ecor

ds th

at d

emon

stra

te th

atau

tom

atic

equ

ipm

ent,

incl

udin

gm

echa

nica

l and

ele

ctro

nic

equi

pmen

t (co

mpu

ters

), us

ed in

the

man

ufac

turi

ng p

roce

ss is

desi

gned

, ins

talle

d, te

sted

,ca

libra

ted,

val

idat

ed,

mai

ntai

ned,

and

che

cked

toen

sure

that

they

are

cap

able

of

and

are

perf

orm

ing

the

inte

nded

func

tions

2132

.39

18.2

050

.77

5052

.92

39.9

365

.53

1083

.25

51.3

495

.90

8147

.93

38.1

457

.88

5.R

ecor

ds fo

r re

proc

essi

ng o

f apr

oduc

t31

46.3

529

.89

63.6

571

78.0

565

.91

86.7

310

79.3

844

.49

94.8

711

267

.24

57.2

875

.85

6.R

ecor

ds to

ass

ure

that

cor

rect

labe

ls a

nd la

belin

g an

d sa

fepa

ckag

ing

mat

eria

ls a

re u

sed

5181

.69

64.8

691

.51

7380

.42

68.4

888

.59

1210

0.00

100.

0010

0.00

136

82.1

973

.50

88.4

7

7.R

ecor

ds to

per

mit

trac

king

the

hist

ory

of th

e m

anuf

actu

ring

proc

ess

5483

.32

65.6

392

.89

8996

.82

92.3

598

.71

1210

0.00

100.

0010

0.00

155

92.3

985

.61

96.1

2

(con

tinue

d)


D-44

Ta

ble

D-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.9

[C

ontin

ued]

8.R

eser

ve s

ampl

es o

f eac

h ba

tch

ofdi

etar

y su

pple

men

t pro

duct

are

reta

ined

and

sto

red

unde

rco

nditi

ons

cons

iste

nt w

ith th

epr

oduc

t lab

elin

g

5180

.88

63.8

791

.01

9096

.04

88.8

898

.66

1210

0.00

100.

0010

0.00

153

91.1

083

.98

95.2

3

No

answ

er2

1.91

0.46

7.58

00.

000.

000.

000

0.00

0.00

0.00

20.

660.

162.

63

7.10

[If

7.6

is Y

es]

How

long

are

rec

ords

on

prod

uctio

npr

oces

ses

reta

ined

?

1.__

___

year

(s) a

fter

expi

ratio

nda

te14

20.4

09.

7937

.69

3438

.29

26.4

551

.71

325

.12

8.11

56.0

751

31.2

422

.73

41.2

4

2.__

___

year

(s) f

rom

dat

e of

man

ufac

ture

3663

.22

46.7

877

.06

4240

.49

29.0

353

.10

645

.88

20.9

673

.05

8448

.68

38.9

058

.55

3.O

ther

910

.21

5.01

19.7

118

21.2

212

.08

34.5

62

20.6

25.

1355

.51

2917

.39

11.0

426

.31

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

8.37

1.12

42.4

11

0.57

0.08

4.03

No

answ

er6

6.18

2.65

13.7

10

0.00

0.00

0.00

00.

000.

000.

006

2.12

0.94

4.71

Mea

n ye

ars

afte

r ex

pira

tion

date

143.

09—

—a

342.

22—

—a

33.

00—

—a

512.

46—

—a

Mea

n ye

ars

from

dat

e of

man

ufac

ture

364.

90—

—a

424.

48—

—a

66.

41—

—a

844.

79—

—a

7.11

[If

7.6

is N

OT

3]D

oes

this

pla

nt u

se p

rodu

ctio

n an

dpr

oces

s co

ntro

ls th

at id

entif

y th

epo

ints

, ste

ps, o

r st

ages

in th

em

anuf

actu

ring

pro

cess

to p

reve

ntad

ulte

ratio

n?

1.Y

es48

56.9

941

.78

70.9

983

77.8

865

.77

86.5

810

76.8

450

.25

91.6

014

170

.09

61.2

777

.64

2.N

o (S

kip

to S

ectio

n 8)

2322

.70

13.1

536

.30

1716

.62

8.98

28.7

22

11.0

52.

6636

.09

4218

.51

12.4

626

.61

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

00

No

answ

er15

20.3

110

.04

36.7

87

5.49

2.36

12.2

52

12.1

12.

8039

.71

2411

.39

6.63

18.8

8

(con

tinue

d)


D-45

Ta

ble

D-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.12

* [

If 7.

11 is

Yes

]D

oes

this

pla

nt’s

pro

duct

ion

and

proc

ess

cont

rols

hav

e sp

ecifi

catio

nsth

at m

ust b

e m

et fo

r id

entit

y, p

urity

,qu

ality

, str

engt

h, a

nd c

ompo

sitio

nof

com

pone

nts,

ingr

edie

nts,

or

diet

ary

supp

lem

ents

and

pac

king

and

labe

ling

mat

eria

ls?

1.Y

es, f

or c

ompo

nent

s31

75.3

161

.18

85.5

145

53.9

439

.99

67.3

010

100.

0010

0.00

100.

0086

63.5

852

.78

73.1

8

2.Y

es, f

or in

gred

ient

s40

88.6

577

.83

94.5

667

83.0

771

.54

90.5

48

75.5

838

.28

93.9

211

584

.22

76.4

089

.80

3.Y

es, f

or d

ieta

ry s

uppl

emen

ts35

81.8

069

.31

89.9

460

70.8

556

.67

81.8

89

90.0

852

.31

98.6

910

475

.49

65.4

883

.33

4.Y

es, f

or p

acki

ng a

nd la

belin

gm

ater

ials

3679

.32

64.7

388

.90

5058

.49

44.2

971

.40

880

.16

45.2

095

.19

9466

.26

55.3

875

.66

5.N

o, n

one

of th

e ab

ove

11.

980.

2613

.40

45.

171.

3318

.09

00.

000.

000.

005

3.85

1.19

11.7

6

No

answ

er1

1.30

0.17

9.04

00.

000.

000.

000

0.00

0.00

0.00

10.

390.

052.

78

(con

tinue

d)


D-46

Ta

ble

D-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.13

* [

If 7.

11 is

Yes

]D

oes

this

pla

nt c

ondu

ct te

sts

tom

onito

r th

e pr

oduc

tion

and

in-

proc

ess

cont

rol p

oint

s, s

teps

, or

stag

es to

ens

ure

the

iden

tity,

pur

ity,

qual

ity, s

tren

gth,

and

com

posi

tion

of c

ompo

nent

s, in

gred

ient

s, o

rdi

etar

y su

pple

men

ts?

1.Y

es, f

or c

ompo

nent

s17

32.6

217

.03

53.3

143

46.0

032

.92

59.6

57

65.6

632

.00

88.6

067

43.3

533

.26

54.0

3

2.Y

es, f

or in

gred

ient

s29

52.6

232

.73

71.7

257

65.9

853

.28

76.7

36

55.7

425

.37

82.3

592

61.2

550

.25

71.2

1

3.Y

es, f

or d

ieta

ry s

uppl

emen

ts27

57.9

037

.42

75.9

954

63.3

049

.26

75.3

98

75.5

838

.28

93.9

289

62.5

351

.51

72.4

0

4.N

o, n

one

of th

e ab

ove

925

.87

10.8

250

.10

1215

.22

7.90

27.3

11

14.5

02.

0158

.36

2218

.37

11.0

129

.04

No

answ

er1

1.30

0.17

9.04

00.

000.

000.

000

0.00

0.00

0.00

10.

390.

052.

78

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


D-47

Ta

ble

D-8

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

8: W

are

ho

usi

ng

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

8.0

Doe

s th

is p

lant

or

site

hav

ew

areh

ouse

s to

sto

re r

aw m

ater

ials

,in

-pro

cess

mat

eria

ls, o

r fin

ishe

dpr

oduc

ts?

1.Y

es10

493

.87

81.5

998

.15

113

99.6

897

.70

99.9

613

95.5

173

.53

99.3

923

096

.94

91.5

298

.93

2.N

o (S

kip

to S

ectio

n 9)

66.

131.

8518

.41

10.

320.

042.

301

4.49

0.61

26.4

78

3.06

1.07

8.48

8.1*

Doe

s yo

ur w

areh

ouse

hav

ete

mpe

ratu

re o

r hu

mid

ity c

ontr

ols?

1.Te

mpe

ratu

re c

ontr

ols

7274

.04

61.1

983

.77

7267

.90

56.2

077

.72

866

.39

38.3

686

.25

152

70.4

062

.28

77.4

1

2.H

umid

ity c

ontr

ols

1319

.27

9.56

35.0

323

23.5

414

.53

35.7

93

27.6

39.

1759

.07

3921

.95

15.1

530

.71

3.N

o te

mpe

ratu

re o

r hu

mid

ityco

ntro

ls32

25.9

616

.23

38.8

141

32.1

022

.28

43.8

05

33.6

113

.75

61.6

478

29.6

022

.59

37.7

2

8.2

Are

ther

e w

ritte

n pr

oced

ures

for

stor

age

proc

edur

es to

con

trol

agai

nst p

hysi

cal,

chem

ical

, and

mic

robi

al a

dulte

ratio

n as

wel

l as

dete

rior

atio

n of

the

prod

uct a

ndco

ntai

ner?

1.Y

es47

49.7

036

.07

63.3

777

66.7

154

.77

76.8

311

87.3

058

.83

97.0

613

560

.62

51.8

568

.74

2.N

o (S

kip

to q

uest

ion

8.7)

5649

.75

36.1

463

.40

3633

.29

23.1

745

.23

212

.70

2.94

41.1

794

39.1

531

.03

47.9

2

No

answ

er1

0.55

0.08

3.90

00.

000.

000.

000

0.00

0.00

0.00

10.

230.

031.

65

(con

tinue

d)


D-48

Ta

ble

D-8

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

8: W

are

ho

usi

ng

(c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

8.3

[If

8.2

is Y

es]

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at th

ese

proc

edur

esar

e be

ing

follo

wed

?

1.Y

es30

68.9

448

.05

84.1

967

92.6

485

.65

96.3

711

100.

0010

0.00

100.

0010

885

.01

76.0

391

.03

2.N

o (S

kip

to q

uest

ion

8.5)

1731

.06

15.8

151

.95

96.

873.

2613

.93

00.

000.

000.

0026

14.7

08.

7223

.72

No

answ

er0

0.00

0.00

0.00

10.

490.

073.

470

0.00

0.00

0.00

10.

280.

042.

02

8.4

[If

8.3

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?1.

Yes

, for

som

e pr

oced

ures

1343

.26

20.7

069

.01

3138

.26

24.5

854

.09

17.

841.

0740

.08

4536

.99

25.7

249

.89

2.Y

es, f

or a

ll pr

oced

ures

1756

.74

30.9

979

.30

2746

.44

31.1

062

.48

983

.02

50.4

495

.92

5352

.52

39.7

364

.99

3.N

o0

0.00

0.00

0.00

711

.60

4.32

27.6

21

9.14

1.20

45.4

78

8.14

3.24

19.0

1N

o an

swer

00.

000.

000.

002

3.70

0.91

13.8

60

0.00

0.00

0.00

22.

340.

588.

96

8.5*

[If

8.2

is Y

es]

Do

your

wri

tten

proc

edur

es fo

rw

areh

ousi

ng in

clud

e an

y of

the

follo

win

g?1.

Proc

edur

es a

nd r

ecor

ds fo

rfo

rwar

d an

d ba

ckw

ard

trac

ing

ofpr

oduc

t

4394

.97

86.3

598

.26

7192

.27

76.9

297

.71

1090

.86

54.7

198

.79

124

93.1

084

.44

97.1

0

2.Pr

oced

ures

and

rec

ords

for

salv

aged

pro

duct

s th

at in

clud

epr

oduc

t exa

min

atio

n an

dre

proc

essi

ng a

s ap

prop

riat

e

2335

.47

19.9

254

.84

5978

.15

64.1

687

.72

1090

.86

54.7

198

.79

9264

.37

52.4

474

.75

No

answ

er3

3.34

1.05

10.0

83

2.32

0.67

7.73

00.

000.

000.

006

2.50

1.09

5.63

(con

tinue

d)


D-49

Ta

ble

D-8

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

8: W

are

ho

usi

ng

(c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

8.6

[If

8.2

is Y

es]

How

long

are

rec

ords

on

war

ehou

sing

ret

aine

d?

1.__

___

year

(s) a

fter

expi

ratio

nda

te14

29.0

614

.09

50.5

527

30.6

619

.55

44.5

82

18.2

84.

4351

.90

4329

.18

20.2

840

.03

2.__

___

year

(s) f

rom

dat

e of

man

ufac

ture

2250

.13

30.1

270

.10

2529

.71

18.4

244

.16

759

.21

28.9

283

.82

5438

.95

28.4

850

.54

3.O

ther

714

.55

4.76

36.7

120

32.2

919

.95

47.7

11

13.3

71.

8455

.88

2824

.76

15.9

636

.32

Don

’t kn

ow1

1.16

0.16

8.10

00.

000.

000.

000

0.00

0.00

0.00

10.

400.

062.

85

No

answ

er3

5.11

1.42

16.8

15

7.35

2.94

17.1

81

9.14

1.21

45.2

99

6.71

3.42

12.7

3

Mea

n ye

ars

afte

r ex

pira

tion

date

141.

97—

—a

272.

29—

—a

24.

00—

—a

432.

26—

—a

Mea

n ye

ars

from

dat

e of

man

ufac

ture

224.

71—

—a

254.

30—

—a

74.

96—

—a

544.

56—

—a

8.7

Are

ther

e w

ritte

n pr

oced

ures

on

prop

er p

reca

utio

ns to

red

uce

the

pote

ntia

l for

mix

-ups

or

adul

tera

tion

or c

onta

min

atio

n of

ingr

edie

nts,

raw

mat

eria

ls, o

r in

-pro

cess

form

ulat

ions

(e.g

., sa

fety

con

trol

s an

d op

erat

ing

prac

tices

or

sepa

ratio

n of

ingr

edie

nts)

?

1.Y

es50

40.3

128

.51

53.3

586

76.0

464

.43

84.7

511

87.3

058

.83

97.0

614

761

.59

52.9

269

.58

2.N

o (S

kip

to S

ectio

n 9)

4444

.34

31.0

858

.46

2521

.67

13.3

633

.18

212

.70

2.94

41.1

771

30.7

523

.23

39.4

4

Not

app

licab

le5

6.24

1.78

19.6

70

0.00

0.00

0.00

00.

000.

000.

005

2.62

0.75

8.80

Don

’t kn

ow2

1.13

0.28

4.51

00.

000.

000.

000

0.00

0.00

0.00

20.

480.

121.

90

No

answ

er3

7.98

2.23

24.8

02

2.29

0.57

8.78

00.

000.

000.

005

4.56

1.65

12.0

0

(con

tinue

d)


D-50

Ta

ble

D-8

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

8: W

are

ho

usi

ng

(c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

8.8

[If

8.7

is Y

es]

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at th

ese

proc

edur

esar

e be

ing

follo

wed

?

1.Y

es41

87.9

077

.28

93.9

577

90.7

382

.13

95.4

211

100.

0010

0.00

100.

0012

990

.63

84.9

394

.32

2.N

o (S

kip

to S

ectio

n 9)

810

.67

5.14

20.8

49

9.27

4.58

17.8

70

0.00

0.00

0.00

178.

975.

3514

.67

No

answ

er1

1.43

0.19

9.84

00.

000.

000.

000

0.00

0.00

0.00

10.

390.

052.

80

8.9

[If

8.8

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es20

45.4

727

.75

64.4

140

47.8

833

.42

62.7

00

0.00

0.00

0.00

6043

.36

32.3

555

.06

2.Y

es, f

or a

ll pr

oced

ures

1434

.39

17.3

556

.68

3041

.99

27.9

757

.44

1090

.86

54.7

198

.79

5443

.91

32.7

755

.70

3.N

o6

9.66

4.08

21.2

17

10.1

34.

1622

.66

19.

141.

2145

.29

149.

935.

2018

.13

No

answ

er1

10.4

81.

4947

.48

00.

000.

000.

000

0.00

0.00

0.00

12.

800.

3718

.09

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


D-51

Ta

ble

D-9

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

9: C

on

sum

er

Co

mp

lain

ts

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

9.1

Are

ther

e w

ritte

n pr

oced

ures

at t

hepl

ant o

r co

rpor

ate

leve

l for

han

dlin

gco

nsum

er c

ompl

aint

s?

1.Y

es52

55.4

442

.10

68.0

385

77.6

867

.24

85.5

213

95.4

973

.42

99.3

915

068

.95

60.9

375

.98

2.N

o (S

kip

to q

uest

ion

9.6)

5542

.96

30.5

156

.38

2619

.71

12.3

529

.95

14.

510.

6126

.58

8229

.01

22.1

636

.99

Not

app

licab

le (S

kip

toSe

ctio

n 10

)2

1.06

0.26

4.23

00.

000.

000.

000

0.00

0.00

0.00

20.

460.

111.

84

No

answ

er1

0.54

0.07

3.82

32.

600.

758.

680

0.00

0.00

0.00

41.

570.

534.

60

9.2

[If

9.1

is Y

es]

Doe

s m

anag

emen

t ver

ify a

nd k

eep

reco

rds

that

thes

e pr

oced

ures

are

bein

g fo

llow

ed?

1.Y

es46

88.9

568

.85

96.7

079

93.9

685

.99

97.5

313

100.

0010

0.00

100.

0013

892

.65

84.9

396

.58

2.N

o (S

kip

to q

uest

ion

9.4)

611

.05

3.30

31.1

56

6.04

2.47

14.0

10

0.00

0.00

0.00

127.

353.

4215

.07

9.3

[If

9.2

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es14

35.6

218

.38

57.6

037

47.0

033

.00

61.4

93

24.3

57.

4956

.15

5441

.40

30.7

352

.96

2.Y

es, f

or a

ll pr

oced

ures

2343

.95

25.1

864

.63

3341

.78

28.1

756

.77

967

.67

37.6

287

.90

6544

.54

33.6

555

.99

3.N

o8

13.3

65.

1030

.67

911

.22

5.09

22.9

21

7.98

1.06

41.1

918

11.6

86.

7019

.59

No

answ

er1

7.07

0.95

37.5

60

0.00

0.00

0.00

00.

000.

000.

001

2.37

0.32

15.5

6

(con

tinue

d)


D-52

Ta

ble

D-9

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

9: C

on

sum

er

Co

mp

lain

ts (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

9.4*

[If

9.1

is Y

es]

Do

your

wri

tten

proc

edur

es fo

rha

ndlin

g co

nsum

er c

ompl

aint

sin

clud

e an

y of

the

follo

win

g?

1.Pr

oced

ures

for

hand

ling

all

wri

tten

and

oral

com

plai

nts

4795

.18

88.5

298

.06

8196

.05

88.6

498

.70

1310

0.00

100.

0010

0.00

141

96.0

491

.92

98.1

0

2.R

ecor

ds c

once

rnin

g th

e ha

ndlin

gof

com

plai

nts

incl

udin

g an

yin

vest

igat

ions

, inv

estig

atio

nfin

ding

s, a

nd fo

llow

-up

actio

nta

ken

3965

.44

44.0

282

.01

7991

.81

78.3

797

.20

1295

.30

72.4

399

.37

130

82.8

571

.90

90.1

2

3.Pr

oced

ures

for

requ

irin

gre

port

ing

of s

erio

us a

dver

seev

ents

to F

DA

MED

WA

TCH

44.

271.

4911

.64

1318

.74

9.71

33.0

94

31.9

212

.26

61.1

621

14.6

48.

6123

.81

Don

’t kn

ow1

0.94

0.13

6.60

00.

000.

000.

000

0.00

0.00

0.00

10.

330.

052.

33

No

answ

er1

0.94

0.13

6.60

00.

000.

000.

000

0.00

0.00

0.00

10.

330.

052.

33

9.5

[If

9.1

is Y

es]

How

long

are

rec

ords

on

cons

umer

com

plai

nts

reta

ined

at t

he p

lant

or

corp

orat

e he

adqu

arte

rs?

1.__

___

year

(s) a

fter

expi

ratio

nda

te11

25.6

011

.59

47.4

435

42.5

429

.40

56.8

22

15.9

63.

9047

.04

4834

.69

24.9

545

.91

2.__

___

year

(s) f

rom

dat

e of

man

ufac

ture

2043

.10

25.1

863

.04

2525

.43

15.6

038

.61

319

.78

6.16

48.0

948

31.1

922

.10

42.0

1

3.O

ther

1621

.27

10.4

438

.50

2532

.03

20.3

546

.51

651

.58

25.7

176

.63

4729

.69

21.0

040

.15

Don

’t kn

ow3

8.16

1.68

31.6

30

0.00

0.00

0.00

00.

000.

000.

003

2.85

0.59

12.7

1

No

answ

er2

1.87

0.46

7.33

00.

000.

000.

002

12.6

82.

9141

.32

41.

580.

564.

33

Mea

n ye

ars

afte

r ex

pira

tion

date

111.

501.

031.

9735

2.22

1.56

2.88

25.

500.

00a

12.1

648

2.14

1.65

2.64

Mea

n ye

ars

from

dat

e of

man

ufac

ture

204.

473.

865.

0925

4.23

3.54

4.91

35.

112.

987.

2548

4.39

3.95

4.82

(con

tinue

d)


D-53

Ta

ble

D-9

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

9: C

on

sum

er

Co

mp

lain

ts (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

9.6*

Wha

t are

you

r pr

oced

ures

for

hand

ling

adve

rse

even

ts a

ssoc

iate

dw

ith c

onsu

mer

com

plai

nts?

1.In

cide

nt is

rep

orte

d to

FD

A15

19.3

79.

9034

.43

1717

.24

9.69

28.7

95

32.1

013

.20

59.5

237

18.9

412

.70

27.3

0

2.Pr

oduc

t is

test

ed fo

r id

entit

y an

dco

mpo

sitio

n66

62.4

048

.41

74.5

883

73.9

862

.49

82.9

18

56.9

930

.46

80.0

415

768

.08

59.5

575

.55

3.Pr

oduc

t is

refo

rmul

ated

1919

.23

10.6

432

.23

3434

.49

23.9

346

.84

534

.13

14.3

661

.56

5827

.88

20.7

936

.28

4.Pr

oduc

t is

reca

lled

5960

.13

46.5

172

.35

7562

.60

50.4

373

.36

641

.75

19.3

368

.20

140

60.4

351

.80

68.4

7

5.O

ther

3425

.62

16.2

537

.93

2222

.15

13.4

234

.29

434

.01

13.5

162

.97

6024

.27

17.6

732

.37

Don

’t kn

ow2

1.05

0.26

4.14

00.

000.

000.

000

0.00

0.00

0.00

20.

450.

111.

79

No

answ

er3

1.62

0.52

4.95

85.

252.

4211

.02

14.

490.

6126

.47

123.

641.

976.

63

9.7

Doe

s th

is p

lant

hav

e a

reca

llpr

oced

ure

in p

lace

?

1.Y

es70

68.4

355

.12

79.2

791

80.1

668

.75

88.1

311

76.7

545

.88

92.7

817

274

.91

66.8

681

.55

2.N

o36

30.4

819

.74

43.8

617

15.1

78.

1426

.53

111

.15

1.56

49.7

554

21.5

715

.30

29.5

2

No

answ

er2

1.10

0.27

4.26

64.

661.

9210

.91

212

.11

2.80

39.6

710

3.51

1.80

6.76

(con

tinue

d)


D-54

Ta

ble

D-9

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

9: C

on

sum

er

Co

mp

lain

ts (

co

nti

nu

ed

)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

9.8*

Who

eva

luat

es r

epor

ts o

nco

nsum

er c

ompl

aint

s?

1.In

-hou

se m

edic

al p

erso

nnel

1611

.10

5.98

19.6

811

10.0

44.

5020

.92

427

.35

10.1

755

.59

3111

.41

7.22

17.5

7

2.In

-hou

se s

cien

tific

per

sonn

el23

23.6

414

.05

36.9

658

53.3

141

.41

64.8

58

53.8

628

.01

77.7

989

40.5

332

.53

49.0

6

3.In

-hou

se q

ualit

y co

ntro

lpe

rson

nel

7061

.61

47.3

574

.13

9382

.84

72.6

889

.76

1392

.38

60.5

398

.97

176

74.1

865

.75

81.1

3

4.In

-hou

se r

egul

ator

y af

fair

spe

rson

nel

1514

.02

6.98

26.1

544

39.6

228

.72

51.6

76

38.6

217

.42

65.2

365

28.5

121

.40

36.8

8

5.O

utsi

de c

ontr

acto

r12

12.4

15.

4625

.80

139.

694.

6119

.23

111

.15

1.56

49.7

526

10.9

46.

4417

.98

6.O

ther

2929

.28

18.2

043

.51

2115

.13

8.79

24.7

81

7.62

1.03

39.4

751

20.8

414

.64

28.7

9

Don

’t kn

ow1

3.52

0.48

21.5

70

0.00

0.00

0.00

00.

000.

000.

001

1.52

0.21

10.2

6

No

answ

er1

0.55

0.08

3.86

31.

920.

526.

900

0.00

0.00

0.00

41.

230.

403.

69

a Est

imat

ed c

onfid

ence

inte

rval

for

low

er b

ound

was

less

than

zer

o so

we

trun

cate

d th

e in

terv

al.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


D-55

Ta

ble

D-1

0. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

10

: Y

ou

r P

lan

t

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

10.1

Wha

t was

the

cale

ndar

yea

rdu

ring

whi

ch th

is p

lant

was

built

? (I

f mul

tiple

bui

ldin

gs, u

seda

te o

f old

est b

uild

ing.

)

Yea

r (m

ean

resp

onse

)80

1981

1977

1985

102

1979

1975

1982

1219

6719

5619

7819

419

7919

7619

82

10.2

Wha

t was

the

cale

ndar

yea

rdu

ring

whi

ch th

e di

etar

ysu

pple

men

t ope

ratio

ns b

egan

at

this

pla

nt?

(If m

ultip

le b

uild

ings

,us

e da

te o

f ear

liest

ope

ratio

n.)

Yea

r (m

ean

resp

onse

)95

1992

1990

1994

103

1989

1986

1991

1319

7119

5819

8321

119

8919

8819

91

10.3

Wha

t is

the

tota

l squ

are

foot

age

of th

is p

lant

?

Squa

re fe

et (m

ean

resp

onse

)91

24,6

7535

548

,994

102

71,3

5552

,980

89,7

3011

595,

734

3,77

11,

187,

696

204

75,7

3342

,203

109,

263

10.4

Are

this

pla

nt’s

faci

litie

sco

nnec

ted

to a

city

wat

er s

uppl

y?

1.Y

es (S

kip

to q

uest

ion

10.6

)86

80.9

068

.58

89.1

688

80.9

069

.92

88.5

312

87.8

960

.33

97.1

918

681

.27

73.8

386

.97

2.N

o17

12.2

06.

2322

.52

2013

.18

7.31

22.6

11

7.62

1.03

39.4

738

12.4

78.

1218

.67

Don

’t kn

ow2

4.00

0.70

19.9

00

0.00

0.00

0.00

00.

000.

000.

002

1.74

0.30

9.37

No

answ

er5

2.89

1.16

7.01

65.

911.

9716

.41

14.

490.

6126

.47

124.

522.

059.

70

(con

tinue

d)


D-56

Ta

ble

D-1

0 W

eig

hte

d R

esp

on

ses

for

Se

cti

on

10

: Y

ou

r P

lan

t (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

10.5

[If 1

0.4

is N

o]Is

the

wat

er s

uppl

y at

this

pla

ntpo

tabl

e?

1.Y

es12

54.4

322

.21

83.3

216

88.2

668

.34

96.3

21

100.

0010

0.00

100.

0029

74.2

542

.21

91.9

2

2.N

o3

12.7

53.

5436

.82

12.

450.

2917

.89

00.

000.

000.

004

6.76

2.54

16.7

7

Don

’t kn

ow0

0.00

0.00

0.00

13.

330.

4122

.35

00.

000.

000.

001

1.81

0.23

12.8

5

No

answ

er2

32.8

27.

1975

.49

25.

951.

2024

.86

00.

000.

000.

004

17.1

93.

3455

.52

10.6

Doe

s yo

ur c

ompa

ny o

wn

plan

ts a

tot

her

loca

tions

?

1.Y

es15

21.4

911

.45

36.6

833

24.5

416

.47

34.9

110

75.7

648

.32

91.2

658

25.9

119

.12

34.0

8

2.N

o90

75.8

961

.11

86.3

274

66.4

054

.60

76.4

63

19.7

56.

1448

.10

167

68.0

859

.55

75.5

5

No

answ

er5

2.62

1.08

6.20

79.

053.

6520

.74

14.

490.

6126

.47

136.

022.

8812

.14

10.7

How

man

y em

ploy

ees

are

curr

ently

em

ploy

ed a

t thi

s pl

ant?

1.Fu

ll-tim

e (m

ean

resp

onse

)10

27.

636.

069.

2010

395

.51

73.2

011

7.81

131,

005.

2330

0.43

1,71

0.03

218

105.

4758

.66

152.

27

2.Pa

rt-t

ime

(mea

n re

spon

se)

5618

.80

0.00

a50

.45

4712

.83

4.39

21.2

66

53.3

015

.74

90.8

710

917

.64

1.04

34.2

3

10.8

How

man

y em

ploy

ees

empl

oyed

at th

is p

lant

are

wor

king

in q

ualit

yco

ntro

l?

1.Fu

ll-tim

e (m

ean

resp

onse

)79

3.01

0.18

5.85

997.

245.

319.

1712

88.2

425

.65

150.

8319

010

.27

5.51

15.0

3

2.Pa

rt-t

ime

(mea

n re

spon

se)

491.

651.

292.

0237

3.28

0.52

6.04

52.

790.

00a

6.71

912.

491.

083.

90

(con

tinue

d)


D-57

Ta

ble

D-1

0 W

eig

hte

d R

esp

on

ses

for

Se

cti

on

10

: Y

ou

r P

lan

t (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

nm

ean

Low

Hig

hn

mea

nLo

wH

igh

nm

ean

Low

Hig

hn

mea

nLo

wH

igh

10.9

For

the

mos

t rec

ent f

isca

l yea

r,pr

ovid

e th

e nu

mbe

r of

bat

ches

of

diet

ary

supp

lem

ent p

rodu

ct b

ypr

oduc

t for

m.

(Mea

n re

spon

se in

batc

hes)

a.Po

wde

r87

49.7

120

.79

78.6

376

120.

5480

.18

160.

9012

85.9

80.

00a

182.

4317

584

.60

59.5

710

9.62

b.Li

quid

8745

.60

25.1

166

.09

7680

.30

30.5

513

0.04

125.

130.

00a

15.0

917

559

.04

33.3

384

.75

c.Pa

ste

870.

040.

00a

0.09

7614

.20

0.00

a38

.12

120.

000.

000.

0017

56.

560.

00a

17.5

9

d.C

apsu

le87

55.5

723

.25

87.8

976

138.

6878

.39

198.

9612

13.5

10.

00a

31.1

917

591

.20

57.4

912

4.91

e.Ta

blet

or

capl

et87

53.9

25.

9110

1.93

7617

1.63

93.5

024

9.77

1217

0.88

39.2

530

2.52

175

115.

4570

.79

160.

10

f.G

elca

p87

0.40

0.00

a1.

0776

18.3

53.

4233

.27

122.

230.

00a

6.46

175

8.78

1.88

15.6

7

g.O

ther

8714

.07

3.90

24.2

576

10.3

32.

0118

.66

1231

.22

0.00

a91

.00

175

13.4

26.

2820

.56

h.O

ther

873.

640.

00a

9.12

760.

040.

00a

0.12

120.

000.

000.

0017

51.

750.

00a

4.35

Tota

l87

222.

9513

4.52

311.

3876

554.

0740

7.25

700.

8912

308.

9618

1.59

436.

3317

538

0.80

292.

6446

8.95

(con

tinue

d)


D-58

Ta

ble

D-1

0 W

eig

hte

d R

esp

on

ses

for

Se

cti

on

10

: Y

ou

r P

lan

t (c

on

tin

ue

d)

Ver

y Sm

all (

n =

110

)Sm

all (

n =

114

)La

rge

(n =

14)

Ove

rall

(n =

238

)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

10.1

0W

hat w

ere

the

gros

s sa

les

reve

nue

for

the

diet

ary

supp

lem

ent

oper

atio

ns o

nly

at th

is p

lant

for

the

mos

t rec

ent f

isca

l yea

r?

1.Le

ss th

an $

500,

000

4734

.11

23.6

646

.37

2114

.30

8.17

23.8

41

4.51

0.61

26.5

869

22.3

916

.66

29.4

0

2.$5

00,0

00 to

just

und

er $

1m

illio

n20

19.6

410

.62

33.4

46

2.68

1.16

6.04

00.

000.

000.

0026

9.90

5.70

16.6

6

3.$1

to ju

st u

nder

$2.

5 m

illio

n18

23.9

713

.42

39.0

610

13.1

76.

1825

.86

16.

540.

9034

.91

2917

.51

11.3

726

.00

4.$2

.5 to

just

und

er $

5 m

illio

n9

7.94

3.39

17.4

97

6.24

2.19

16.5

11

7.62

1.03

39.4

717

7.05

3.70

13.0

3

5.$5

to ju

st u

nder

$10

mill

ion

20.

920.

223.

7624

24.0

014

.89

36.3

12

12.1

12.

8139

.67

2813

.35

8.33

20.7

2

6.$1

0 to

just

und

er $

20 m

illio

n3

1.63

0.51

5.05

1410

.32

5.77

17.8

02

15.2

43.

7745

.23

196.

814.

2210

.80

7.$2

0 to

just

und

er $

50 m

illio

n2

4.00

0.70

19.9

012

12.7

66.

6323

.14

212

.35

2.89

40.0

216

8.93

4.94

15.6

2

8.$5

0 to

just

und

er $

100

mill

ion

00.

000.

000.

002

0.92

0.23

3.56

218

.77

4.70

51.9

74

1.46

0.51

4.11

9.$1

00 to

just

und

er $

500

mill

ion

13.

490.

4821

.37

55.

342.

2212

.27

215

.24

3.77

45.2

38

5.06

2.30

10.7

5

10.$

500

mill

ion

or m

ore

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

Don

’t kn

ow0

0.00

0.00

0.00

21.

580.

347.

030

0.00

0.00

0.00

20.

810.

183.

66

No

answ

er8

4.31

2.09

8.66

118.

694.

5915

.86

17.

621.

0339

.47

206.

734.

2010

.61

a Est

imat

ed c

onfid

ence

inte

rval

for

low

er b

ound

was

less

than

zer

o so

we

trun

cate

d th

e in

terv

al.


D-59

Ta

ble

D-1

1. V

erb

ati

ms

for

Qu

est

ion

2.4

: W

hy

Do

es

this

Pla

nt

No

t F

ollo

w P

ub

lish

ed

GM

Ps?

Ver

y Sm

all

It is

not

a m

anuf

actu

ring

faci

lity.

Jus

t a s

ales

and

mar

ketin

g si

te.

All

prod

ucts

dis

trib

uted

are

pro

duce

d by

oth

er c

ompa

nies

in fa

cilit

ies

who

lly w

ithin

thei

r co

ntro

l.

We

sub-

cont

ract

with

pac

kagi

ng c

ompa

nies

for

actu

al s

uppl

emen

t man

ufac

turi

ng. (

We

do n

ot h

ave

prod

uctio

n fa

cilit

y).

OEM

cus

tom

ers

do n

ot w

ant t

o pa

y fo

r ex

tens

ive

cost

s, i.

e. la

b te

sts

of r

aw m

ater

ials

eve

n fin

ishe

d pr

oduc

ts.

Don

’t m

anuf

actu

re—

we

rely

on

man

ufac

ture

rs.

Not

a p

lant

.

We

do n

ot m

anuf

actu

re p

rodu

cts,

we

dist

ribu

te fi

nish

ed p

rodu

cts

only

.

Prop

osed

rul

e m

akin

g no

t fin

aliz

ed.

Ver

y ex

pens

ive—

we

are

smal

l.

We

don’

t man

ufac

ture

.

Do

not u

nder

stan

d ex

act m

eani

ng.

We

are

not m

anuf

actu

rer

in th

is p

lace

. Onl

y of

fice

here

.

Cur

rent

pro

gram

str

onge

r th

an G

MPs

.

Not

a m

anuf

actu

rer—

only

res

ell b

ulk

ingr

edie

nts.

We

impo

rt p

rodu

cts

that

are

mad

e ov

erse

as a

nd d

epen

d on

our

sup

plie

rs to

follo

w G

MP

stan

dard

s.

Prod

ucts

pro

duce

d by

app

rove

d ve

ndor

.

Not

sur

e ho

w G

MPs

app

ly to

my

com

pany

. Too

bus

y st

rugg

ling

to s

urvi

ve to

find

out

.

Our

pla

nt is

sta

ffed

by o

nly

two

peop

le—

mys

elf a

nd m

y w

ife. W

e si

mpl

y w

areh

ouse

and

re-

ship

pro

duct

s w

hich

are

pac

ked

by p

riva

teco

mpa

nies

.

Not

fam

iliar

.

We

man

ufac

ture

sin

gle

herb

tea

grow

n on

our

bio

logi

cal r

eser

ve. A

s a

smal

l com

pany

with

one

pro

duct

that

we

cont

rol f

rom

see

d to

mat

ure

plan

t.

Not

fam

iliar

with

them

.

Not

req

uire

d.

(con

tinue

d)


D-60

Ta

ble

D-1

1. V

erb

ati

ms

for

Qu

est

ion

2.4

: W

hy

Do

es

this

Pla

nt

No

t F

ollo

w P

ub

lish

ed

GM

Ps?

(c

on

tin

ue

d)

Ver

y Sm

all (

cont

inue

d)

It is

not

a m

anuf

actu

ring

faci

lity.

Jus

t a s

ales

and

mar

ketin

g si

te.

Too

cost

ly a

nd u

nnec

essa

ry in

our

situ

atio

n.

Not

app

licab

le—

we

don’

t man

ufac

ture

pro

duct

s.

Do

not h

ave

enou

gh in

form

atio

n—w

ill s

et u

p in

200

0.

We

do n

ot m

anuf

actu

re.

We

are

just

a s

ales

and

mar

ketin

g of

fice.

I don

’t th

ink

they

are

ade

quat

e fo

r bo

tani

cal i

dent

ity.

It do

esn’

t see

m n

eces

sary

. We

know

the

cont

ents

/pur

ity o

f the

goo

ds w

e m

ake,

and

hav

e ou

r ow

n st

anda

rds

for

puri

ty a

nd s

anita

tion.

Publ

ishe

d pr

oced

ures

are

gen

eral

ly n

ot a

pplic

able

or

prac

tical

for

an h

erba

l man

ufac

turi

ng c

ompa

ny o

f our

siz

e.

We

do n

ot tr

ust t

he in

tent

of t

he in

spec

tors

. We

are

afra

id th

at th

ey m

ay a

cqui

re p

ropr

ieta

ry m

anuf

actu

ring

pra

ctic

es fr

om u

s.

I was

told

by

an F

DA

sta

ff m

embe

r th

at G

MPs

did

not

app

ly to

our

ope

ratio

n.

Onl

y be

caus

e I d

on’t

have

a c

opy

of p

ublis

hed

GM

Ps a

nd d

idn’

t kno

w w

here

to a

cces

s th

is in

form

atio

n.

Una

vaila

ble—

guid

elin

es n

ot e

stab

lishe

d.

GM

P no

t rea

dily

ava

ilabl

e an

d th

e ex

pens

e in

volv

ed.

Not

a m

anuf

actu

rer.

Man

ufac

turi

ng is

not

don

e at

this

pla

nt b

ut it

ems

in q

uest

ion

2.3

are

kept

on

file

by o

ur s

uppl

ier.

We

empl

oy th

e se

rvic

es o

f con

trac

t man

ufac

ture

rs fo

r al

l our

pro

duct

s. C

onse

quen

tly, t

he q

uest

ions

in s

ectio

ns 3

-7 a

re n

ot a

pplic

able

.

Smal

l I don

’t m

anuf

actu

re a

nyth

ing

or e

ncap

sula

te a

nyth

ing—

I’m n

ot a

pla

nt.

Dis

trib

utio

n on

ly.

Lim

ited

reso

urce

s.

We

are

stri

ctly

a d

istr

ibut

or a

nd r

ely

on o

ur v

endo

rs to

hav

e G

MPs

.

We

are

a bu

sine

ss o

ffice

.

Cur

rent

ope

ratio

ns h

ave

prov

en a

dequ

ate

and

safe

ove

r m

any

year

s. T

hous

ands

of s

atis

fied

cust

omer

s w

ith v

ery

few

com

plai

nts.

(con

tinue

d)


D-61

Ta

ble

D-1

1. V

erb

ati

ms

for

Qu

est

ion

2.4

: W

hy

Do

es

this

Pla

nt

No

t F

ollo

w P

ub

lish

ed

GM

Ps?

(c

on

tin

ue

d)

Smal

l (co

ntin

ued)

Not

eco

nom

ical

ly fe

asib

le.

Too

cost

ly to

impl

emen

t.

We

hand

le 8

0-90

% r

aw m

ater

ials

of h

erbs

—on

ly a

bout

5 k

inds

of h

erbs

that

’s a

ll.

In d

evel

opm

ent a

t thi

s tim

e.

Die

tary

sup

plem

ent p

rodu

ct li

nes

are

not e

xten

sive

eno

ugh

to w

arra

nt fo

llow

ing

a pu

blis

hed

GM

P m

odel

.

We

are

not a

war

e of

pub

lishe

d G

MPs

for

impo

rter

s w

ho d

o no

t eve

r op

en d

rum

s. T

he p

rodu

cers

follo

w p

ublis

hed

GM

P.

We

do n

ot m

anuf

actu

re o

r bo

ttle

the

prod

uct—

Onl

y pr

ivat

e la

bel a

nd d

istr

ibut

e.

We

are

not a

man

ufac

ture

r an

d th

is is

not

a p

lant

.

We

are

in th

e pr

oces

s of

impl

emen

ting

new

pro

cedu

res.

We

follo

w s

peci

fic p

roce

dure

s de

fined

by

clie

nts

and

we

are

usin

g ou

r ow

n G

MP

syst

em.

We

feel

we

have

GM

Ps in

pla

ce. T

hey

just

are

n’t t

he G

MPs

that

som

eone

els

e es

tabl

ishe

d, th

ey’r

e ar

e [s

ic]

own.

Wor

k in

pro

cess

. Goa

l to

be b

y 6/

2000

.

Non

e of

the

actu

al m

anuf

actu

ring

don

e at

this

loca

tion.

We

are

not m

anuf

actu

rer.

Our

man

ufac

ture

r fo

llow

s C

hina

’s a

nd/o

r A

ustr

alia

’s G

MPs

.

Raw

ingr

edie

nt s

uppl

ier.

We

are

a di

stri

buto

r.

We

are

a fa

rm a

nd p

rodu

ce b

ulk

herb

s m

ostly

.

Con

trac

t man

ufac

ture

rs—

mak

e an

d pa

ckag

e ou

r pr

oduc

ts—

we

repa

ckag

e in

to p

oint

of s

ale

disp

lays

onl

y.

Loca

l san

itatio

n de

pt s

tand

ards

.

Appendix E:Weighted Results byProduct Type

E-1

The results for each section of the survey are reported in a separatetable (e.g., Table E-1 corresponds to Section 1 of the survey). Foreach question response item, we provide the number ofrespondents who circled that answer (n), the proportion ofrespondents who circled that answer (%), and the 95 percentconfidence interval for the point estimate (Low and High values).Where appropriate, we report the mean response.

The totals for a question may not always sum to 100 percent due torounding. We have indicated with an (*) when respondents couldselect more than one response.

Because of the skip patterns, the number of respondents varies byquestion. We excluded from the analysis respondents whoappropriately skipped questions. For example, respondents whoanswered 2 (No) to Question 2.5 were not included in thefrequency for Question 2.6.


E-2

Ta

ble

E-1

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

1: P

rod

uc

ts a

nd

Ma

rke

ts

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

1.1*

Whi

ch o

f the

follo

win

g de

scri

bes

the

diet

ary

supp

lem

ent o

pera

tions

at

this

pla

nt?

1.M

anuf

actu

rer—

man

ufac

ture

diet

ary

supp

lem

ents

from

ingr

edie

nts,

may

pac

kage

and

labe

l the

pro

duct

itse

lf or

tran

sfer

it to

a r

epac

kage

r/re

labe

ler/

enca

psul

ator

or

dist

ribu

tor

7763

.54

51.7

173

.94

743

.26

21.8

167

.57

5960

.77

47.6

072

.54

347

.28

16.0

980

.74

2.R

epac

kage

r/re

labe

ler/

enca

psul

ator

—re

pack

age,

rela

bel,

or e

ncap

sula

te d

ieta

rysu

pple

men

ts m

anuf

actu

red

byan

othe

r fir

m

5042

.57

31.6

354

.29

317

.92

5.70

44.0

813

16.4

77.

9331

.09

117

.58

2.37

65.2

2

3.In

gred

ient

or

inpu

t sup

plie

r—su

pply

ingr

edie

nts

or b

ulk

finis

hed

prod

ucts

use

d to

man

ufac

ture

die

tary

sup

plem

ents

at th

is p

lant

or

anot

her

firm

3828

.51

19.2

739

.98

424

.47

9.31

50.5

634

37.7

025

.60

51.5

63

35.2

111

.07

70.3

4

4.D

istr

ibut

or—

dist

ribu

te p

rodu

cts

man

ufac

ture

d by

this

pla

nt o

ran

othe

r fir

m

7661

.29

49.4

171

.96

744

.79

22.7

869

.05

4844

.53

32.3

957

.36

459

.34

23.5

487

.37

5.Im

port

er—

impo

rt e

ither

ingr

edie

nts

for

furt

her

proc

essi

ngor

fini

shed

pro

duct

s fo

rdi

stri

butio

n

3632

.37

22.3

544

.32

530

.73

13.2

356

.37

3024

.89

16.9

335

.01

223

.67

5.68

61.4

7

6.Ex

port

er—

expo

rt e

ither

ingr

edie

nts

for

furt

her

proc

essi

ngor

fini

shed

pro

duct

s fo

rdi

stri

butio

n

4636

.88

26.5

348

.59

424

.18

9.04

50.5

729

30.3

219

.57

43.7

61

12.1

21.

6353

.50

7.O

ther

43.

831.

0512

.92

16.

260.

8334

.72

54.

131.

729.

590

0.00

0.00

0.00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

002

3.06

0.67

12.8

10

0.00

0.00

0.00

(con

tinue

d)

Appendix E — Weighted Results by Product Type

E-3

Ta

ble

E-1

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

1: P

rod

uc

ts a

nd

Ma

rke

ts (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

1.2

For

your

die

tary

sup

plem

ent

oper

atio

ns a

t thi

s pl

ant,

wha

t is

the

prod

uct t

ype

for

your

pri

mar

y lin

e of

busi

ness

?a

1.V

itam

ins

and

min

eral

s60

53.2

441

.82

64.3

20

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

2.H

erba

ls a

nd b

otan

ical

s, n

otin

clud

ing

extr

acts

1615

.70

8.54

27.1

01

5.97

0.82

32.7

441

39.3

628

.12

51.8

40

0.00

0.00

0.00

3.H

erba

l and

bot

anic

al e

xtra

cts

2115

.44

8.92

25.3

82

11.6

62.

9136

.72

4137

.19

26.9

648

.71

00.

000.

000.

00

4.A

min

o ac

ids

10.

350.

052.

483

18.7

96.

1245

.06

00.

000.

000.

000

0.00

0.00

0.00

5.Pr

otei

n pr

oduc

ts4

3.31

0.81

12.5

27

45.3

723

.07

69.7

00

0.00

0.00

0.00

00.

000.

000.

00

6.A

nim

al e

xtra

cts

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

7.C

once

ntra

tes,

met

abol

ites,

and

cons

titue

nts

22.

500.

4113

.77

00.

000.

000.

000

0.00

0.00

0.00

229

.64

7.09

69.9

3

8.O

ther

33.

010.

6412

.92

00.

000.

000.

003

12.1

83.

7333

.20

570

.36

30.0

792

.91

Res

pond

ent s

elec

ted

mul

tiple

resp

onse

s9

5.74

2.87

11.1

53

18.2

15.

8144

.56

1110

.40

5.39

19.1

20

0.00

0.00

0.00

Non

-die

tary

sup

plem

ent p

rodu

ct2

0.72

0.18

2.87

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

0.88

0.12

6.12

00.

000.

000.

00

(con

tinue

d)


E-4

Ta

ble

E-1

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

1: P

rod

uc

ts a

nd

Ma

rke

ts (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

1.3*

Wha

t oth

er p

rodu

ct ty

pes,

not

incl

udin

g yo

ur p

rim

ary

line

ofbu

sine

ss, d

o yo

u pr

oduc

e at

this

plan

t? B

y pr

oduc

e w

e m

ean,

man

ufac

ture

, rep

ack/

rela

bel/

enca

psul

ate,

sup

ply

ingr

edie

nts,

dist

ribu

te, i

mpo

rt, o

r ex

port

.

1.V

itam

ins

and

min

eral

s58

46.7

635

.68

58.1

80

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

2.H

erba

ls a

nd b

otan

ical

s, n

otin

clud

ing

extr

acts

6759

.76

48.0

570

.46

15.

690.

7931

.29

2937

.58

25.4

551

.49

00.

000.

000.

00

3.H

erba

l and

bot

anic

al e

xtra

cts

4840

.26

29.5

751

.96

529

.87

12.6

255

.69

3232

.92

22.4

145

.47

00.

000.

000.

00

4.A

min

o ac

ids

5245

.79

34.8

357

.19

318

.79

6.12

45.0

60

0.00

0.00

0.00

00.

000.

000.

00

5.Pr

otei

n pr

oduc

ts39

34.8

424

.78

46.4

52

12.2

42.

9538

.98

00.

000.

000.

000

0.00

0.00

0.00

6.A

nim

al e

xtra

cts

2222

.49

13.8

534

.38

529

.87

12.6

255

.69

00.

000.

000.

000

0.00

0.00

0.00

7.C

once

ntra

tes,

met

abol

ites,

and

cons

titue

nts

2423

.68

15.0

235

.25

318

.50

5.87

45.2

52

3.02

0.66

12.7

70

0.00

0.00

0.00

8.O

ther

30.

950.

302.

962

12.5

23.

0739

.25

22.

160.

518.

611

12.1

21.

6353

.50

Non

-die

tary

sup

plem

ent p

rodu

ct11

6.39

3.46

11.5

14

24.1

89.

0450

.57

87.

923.

6616

.29

00.

000.

000.

00

No

othe

r pr

oduc

t typ

es10

9.08

4.15

18.7

43

21.1

86.

9049

.36

2924

.18

16.4

734

.03

687

.88

46.5

098

.37

1.4

Doe

s th

is p

lant

pro

duce

any

food

prod

ucts

oth

er th

an d

ieta

rysu

pple

men

ts?

1.Y

es26

19.5

112

.10

29.9

25

31.0

213

.27

56.9

420

19.4

712

.03

29.9

61

17.5

82.

3765

.22

2.N

o91

79.6

269

.18

87.1

811

68.9

843

.06

86.7

375

78.3

767

.55

86.3

16

82.4

234

.78

97.6

3

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

0.88

0.12

6.12

00.

000.

000.

00

No

answ

er1

0.87

0.12

6.02

00.

000.

000.

001

1.28

0.18

8.71

00.

000.

000.

00

(con

tinue

d)


E-5

Ta

ble

E-1

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

1: P

rod

uc

ts a

nd

Ma

rke

ts (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

1.5

Doe

s th

is p

lant

pro

duce

any

ove

r-th

e-co

unte

r (O

TC) o

r pr

escr

iptio

n(R

x) d

rugs

?

1.Y

es, O

TC d

rugs

179.

735.

9715

.47

211

.37

2.91

35.4

610

10.1

35.

1418

.98

117

.58

2.37

65.2

2

2.Y

es, R

x dr

ugs

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

3.Y

es, O

TC a

nd R

x dr

ugs

1510

.86

5.98

18.9

13

18.5

05.

8745

.25

10.

840.

125.

860

0.00

0.00

0.00

4.N

o84

76.6

867

.77

83.7

111

70.1

344

.31

87.3

884

86.8

877

.52

92.7

06

82.4

234

.78

97.6

3

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

0.88

0.12

6.12

00.

000.

000.

00

No

answ

er2

2.73

0.62

11.1

50

0.00

0.00

0.00

11.

280.

188.

710

0.00

0.00

0.00

1.6*

Is

this

pla

nt a

mem

ber

of a

ny o

f the

follo

win

g tr

ade

orga

niza

tions

?

1.A

mer

ican

Her

bal P

rodu

cts

Ass

ocia

tion

(AH

PA)

3016

.48

11.1

523

.68

15.

970.

8232

.74

5246

.70

34.8

158

.98

00.

000.

000.

00

2.C

onsu

mer

Hea

lth P

rodu

cts

Ass

ocia

tion

(CH

PA) (

form

erly

know

n as

Non

pres

crip

tion

Dru

gM

anuf

actu

rers

Ass

ocia

tion)

128.

924.

4816

.97

00.

000.

000.

003

2.56

0.81

7.83

117

.58

2.37

65.2

2

3.C

ounc

il fo

r R

espo

nsib

leN

utri

tion

(CR

N)

2321

.81

13.6

832

.92

16.

260.

8334

.72

87.

883.

6516

.20

00.

000.

000.

00

4.N

atio

nal N

utri

tiona

l Foo

dsA

ssoc

iatio

n (N

NFA

)60

52.6

241

.13

63.8

58

48.0

825

.32

71.6

742

44.3

031

.84

57.5

23

41.7

613

.14

77.2

6

5.U

tah

Nat

ural

Pro

duct

s A

llian

ce(U

NPA

)5

2.12

0.83

5.30

00.

000.

000.

001

2.18

0.31

13.9

70

0.00

0.00

0.00

6.O

ther

1715

.31

8.70

25.5

43

20.6

16.

7348

.31

1512

.81

7.47

21.0

91

12.0

61.

6253

.34

Not

app

licab

le35

25.4

516

.93

36.3

96

37.0

017

.28

62.2

722

25.1

314

.99

38.9

73

40.6

612

.63

76.4

6

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

0.88

0.12

6.12

00.

000.

000.

00

a The

pri

mar

y lin

e of

bus

ines

s is

the

line

of b

usin

ess

that

con

trib

utes

to th

e m

ajor

ity o

f rev

enue

s—ei

ther

gre

ater

than

50

perc

ent o

f rev

enue

s or

the

grea

test

of s

ever

allin

es s

uch

as 3

5 pe

rcen

t if a

ll ot

her

lines

con

trib

ute

less

.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


E-6

Ta

ble

E-2

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

2: G

oo

d M

an

ufa

ctu

rin

g P

rac

tic

es

(GM

Ps)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

2.1

Doe

s th

is p

lant

follo

w a

pub

lishe

dG

ood

Man

ufac

turi

ng P

ract

ices

(GM

Ps) m

odel

for

the

diet

ary

supp

lem

ent p

rodu

cts

prod

uced

at

this

pla

nt?

1.Y

es89

67.5

855

.79

77.5

010

61.1

836

.00

81.5

457

59.3

146

.23

71.1

83

41.2

412

.85

76.9

7

2.N

o (S

kip

to q

uest

ion

2.3)

2228

.93

19.4

340

.74

532

.56

14.1

758

.54

3231

.67

20.9

344

.81

458

.76

23.0

387

.15

Not

app

licab

le (S

kip

toqu

estio

n 2.

3)4

1.41

0.53

3.66

16.

260.

8334

.72

32.

960.

919.

190

0.00

0.00

0.00

No

answ

er3

2.07

0.62

6.72

00.

000.

000.

005

6.06

2.32

14.9

00

0.00

0.00

0.00

2.2*

[If

2.1

is Y

es]

Whi

ch o

f the

follo

win

g ar

e yo

urG

MPs

for

diet

ary

supp

lem

ent

oper

atio

ns p

atte

rned

afte

r?

1.FD

A F

ood

CG

MPs

(21

CFR

Par

t11

0)55

66.4

656

.09

75.4

57

69.2

936

.69

89.7

834

57.1

940

.01

72.8

03

100.

0010

0.00

100.

00

2.A

dvan

ce N

otic

e of

Pro

pose

dR

ulem

akin

g fo

r D

ieta

rySu

pple

men

ts

2834

.87

23.3

148

.52

00.

000.

000.

0013

26.2

113

.28

45.1

80

0.00

0.00

0.00

3.N

atio

nal N

utri

tiona

l Foo

dsA

ssoc

iatio

n (N

NFA

) GM

Ps23

26.7

516

.52

40.2

62

19.0

64.

8052

.36

1331

.86

16.4

752

.56

129

.40

3.51

82.6

5

4.FD

A D

rug

CG

MPs

(21

CFR

Par

ts21

0 an

d 21

1)36

37.3

725

.72

50.7

04

40.9

416

.67

70.6

28

11.2

05.

4021

.80

00.

000.

000.

00

5.U

.S. P

harm

acop

eia

(USP

) GM

Ps30

37.0

525

.32

50.5

43

30.7

110

.22

63.3

19

15.9

27.

7130

.02

00.

000.

000.

00

6.O

ther

55.

831.

9716

.03

110

.24

1.33

49.1

111

23.0

110

.27

43.8

31

27.9

93.

3081

.58

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

1.48

0.20

10.1

50

0.00

0.00

0.00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

1.42

0.19

9.77

00.

000.

000.

00

(Ski

p to

que

stio

n 2.

5)

(con

tinue

d)


E-7

Ta

ble

E-2

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

2: G

oo

d M

an

ufa

ctu

rin

g P

rac

tic

es

(GM

Ps)

(c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

2.3*

[If

2.1

is N

o]If

not f

ollo

win

g pu

blis

hed

GM

Ps,

how

doe

s th

is p

lant

ver

ify th

eid

entit

y, p

urity

, and

com

posi

tion

ofdi

etar

y su

pple

men

t pro

duct

s an

din

gred

ient

s?

1.Sa

nita

tion

stan

dard

ope

ratin

gpr

oced

ures

(SSO

Ps)

722

.41

——

a1

16.1

3—

—a

510

.96

——

a1

29.9

2—

—a

2.O

ther

qua

lity

assu

ranc

e (Q

A)

prog

ram

624

.54

——

a1

16.1

3—

—a

1229

.03

——

a1

20.5

2—

—a

3.C

ertif

icat

e of

Ana

lysi

s19

83.9

7—

—a

463

.04

——

a20

47.4

9—

—a

370

.08

——

a

4.C

ertif

icat

e of

Iden

tity

513

.65

——

a3

46.9

1—

—a

716

.67

——

a1

20.5

2—

—a

5.O

ther

1144

.07

——

a2

38.4

4—

—a

1125

.96

——

a0

0.00

——

a

Not

app

licab

le2

2.21

——

a0

0.00

——

a5

27.2

9—

—a

00.

00—

—a

No

answ

er1

1.22

——

a0

0.00

——

a0

0.00

——

a0

0.00

——

a

2.4

[If 2

.1 is

No]

Why

doe

s th

is p

lant

not

follo

wpu

blis

hed

GM

Ps?

(ver

batim

s pr

ovid

ed in

Tab

le E

-11)

2.5

Doe

s th

is p

lant

hav

e st

anda

rdop

erat

ing

proc

edur

es (S

OPs

)?

1.Y

es10

282

.13

70.5

689

.81

1060

.32

34.9

181

.16

7978

.10

63.9

187

.77

458

.82

23.0

787

.19

2.N

o (S

kip

to S

ectio

n 3)

1011

.49

5.42

22.7

41

5.97

0.82

32.7

410

13.3

25.

5328

.74

341

.18

12.8

176

.93

Not

app

licab

le2

0.67

0.17

2.63

18.

661.

2541

.58

32.

960.

919.

190

0.00

0.00

0.00

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

0.84

0.12

5.86

00.

000.

000.

00

No

answ

er4

5.71

1.83

16.4

44

25.0

59.

7550

.83

44.

781.

6013

.38

00.

000.

000.

00

(con

tinue

d)


E-8

Ta

ble

E-2

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

2: G

oo

d M

an

ufa

ctu

rin

g P

rac

tic

es

(GM

Ps)

(c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

2.6

[If 2

.5 is

Yes

]Is

ther

e w

ritte

n do

cum

enta

tion

ofth

e SO

Ps?

1.Y

es88

82.9

470

.68

90.7

58

80.1

945

.17

95.2

160

80.3

970

.11

87.7

53

70.1

218

.37

96.0

7

2.N

o6

8.96

3.52

20.9

81

9.43

1.30

45.2

011

11.4

26.

1820

.13

129

.88

3.93

81.6

3

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

1.12

0.15

7.78

00.

000.

000.

00

No

answ

er8

8.10

3.41

18.0

11

10.3

81.

3749

.21

77.

073.

2614

.66

00.

000.

000.

00

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


E-9

Ta

ble

E-3

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

3: P

ers

on

ne

l

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

3.0

Do

pers

onne

l at t

his

plan

t or

site

hand

le r

aw m

ater

ials

, in-

proc

ess

mat

eria

ls, o

r fin

ishe

d pr

oduc

ts,

incl

udin

g di

stri

butio

n of

fini

shed

prod

ucts

?

1.Y

es11

193

.25

83.2

397

.47

1485

.08

55.6

096

.29

8887

.74

72.0

395

.21

564

.85

26.0

190

.63

2.N

o (S

kip

to S

ectio

n 4)

76.

752.

5316

.77

214

.92

3.71

44.4

09

12.2

64.

7927

.97

235

.15

9.37

73.9

9

3.1

Are

ther

e w

ritte

n pr

oced

ures

for

pers

onne

l on

dise

ase

cont

rol?

1.Y

es76

69.7

257

.72

79.5

39

64.2

136

.70

84.7

448

60.8

348

.76

71.7

11

27.1

13.

9577

.08

2.N

o34

29.9

220

.15

41.9

45

35.7

915

.26

63.3

039

38.2

127

.50

50.2

04

72.8

922

.92

96.0

5

Not

app

licab

le1

0.36

0.05

2.53

00.

000.

000.

001

0.96

0.13

6.65

00.

000.

000.

00

3.2

Are

ther

e w

ritte

n pr

oced

ures

for

pers

onne

l on

mai

ntai

ning

per

sona

lcl

eanl

ines

s?

1.Y

es96

81.1

069

.13

89.1

612

85.2

855

.77

96.3

865

77.2

966

.96

85.1

12

45.8

012

.12

83.8

2

2.N

o14

18.5

410

.53

30.5

52

14.7

23.

6244

.23

2221

.76

14.1

431

.94

354

.20

16.1

887

.88

Not

app

licab

le1

0.36

0.05

2.53

00.

000.

000.

001

0.96

0.13

6.65

00.

000.

000.

00

3.3

Are

ther

e w

ritte

n pr

oced

ures

ensu

ring

that

all

pers

onne

lem

ploy

ed in

the

man

ufac

turi

ngpr

oces

s ha

ve th

e pr

oper

edu

catio

n,tr

aini

ng, o

r ex

peri

ence

nee

ded

tope

rfor

m th

e as

sign

ed fu

nctio

ns?

1.Y

es82

67.9

055

.42

78.2

612

85.6

256

.03

96.5

351

57.0

243

.93

69.1

92

45.8

012

.12

83.8

2

2.N

o27

29.3

319

.38

41.7

42

14.3

83.

4743

.97

3338

.40

26.6

351

.72

354

.20

16.1

887

.88

Not

app

licab

le1

0.36

0.05

2.53

00.

000.

000.

004

4.58

1.65

12.0

70

0.00

0.00

0.00

No

answ

er1

2.41

0.33

15.7

10

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

(con

tinue

d)


E-10

Ta

ble

E-3

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

3: P

ers

on

ne

l (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

3.4

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at th

e pr

oced

ures

for

pers

onne

l on

dise

ase

cont

rol,

pers

onal

cle

anlin

ess,

and

trai

ning

are

bein

g fo

llow

ed?

1.Y

es79

67.5

455

.40

77.7

19

63.8

836

.62

84.4

042

47.9

235

.28

60.8

32

45.8

012

.12

83.8

2

2.N

o (S

kip

to q

uest

ion

3.6)

3029

.68

19.8

541

.84

536

.12

15.6

063

.38

4242

.23

30.6

654

.71

354

.20

16.1

887

.88

Not

app

licab

le1

0.36

0.05

2.53

00.

000.

000.

002

2.42

0.57

9.66

00.

000.

000.

00

No

answ

er1

2.41

0.33

15.7

10

0.00

0.00

0.00

27.

441.

3931

.38

00.

000.

000.

00

3.5

[If 3

.4 is

Yes

]A

re r

ecor

ds m

ade

of a

ny c

orre

ctiv

eac

tions

take

n if

proc

edur

es a

re n

otfo

llow

ed?

1.Y

es, f

or s

ome

proc

edur

es38

50.9

337

.00

64.7

16

65.4

332

.07

88.3

522

46.0

428

.93

64.1

41

59.1

88.

1195

.97

2.Y

es, f

or a

ll pr

oced

ures

2631

.03

19.6

645

.28

223

.05

5.67

59.8

912

35.0

218

.30

56.4

61

40.8

24.

0391

.89

3.N

o9

13.5

36.

0427

.61

00.

000.

000.

006

14.8

56.

0232

.21

00.

000.

000.

00

No

answ

er6

4.50

1.90

10.3

11

11.5

21.

4952

.93

24.

090.

9715

.70

00.

000.

000.

00

3.6

Are

rec

ords

mai

ntai

ned

of p

erso

nnel

educ

atio

n, tr

aini

ng, o

r ex

peri

ence

?

1.Y

es82

69.9

757

.61

79.9

811

78.6

049

.84

93.1

355

58.5

745

.26

70.7

32

45.8

012

.12

83.8

2

2.N

o (S

kip

to S

ectio

n 4)

2829

.67

19.6

942

.06

321

.40

6.87

50.1

631

38.9

726

.95

52.5

13

54.2

016

.18

87.8

8

Not

app

licab

le1

0.36

0.05

2.53

00.

000.

000.

002

2.46

0.58

9.77

00.

000.

000.

00

(con

tinue

d)


E-11

Ta

ble

E-3

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

3: P

ers

on

ne

l (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

3.7

[If 3

.6 is

Yes

]H

ow lo

ng a

re r

ecor

ds o

f per

sonn

eled

ucat

ion,

trai

ning

, or

expe

rien

cem

aint

aine

d?

1.Te

rm o

f em

ploy

men

t52

63.9

4—

—a

327

.23

——

a31

50.0

6—

—a

159

.18

——

a

2.__

_ Y

ear(

s) a

fter

expi

ratio

n da

te6

7.31

——

a1

8.93

——

a3

7.09

——

a0

0.00

——

a

3.__

_ Y

ear(

s) fr

om d

ate

ofm

anuf

actu

re3

3.21

——

a2

18.3

0—

—a

312

.50

——

a0

0.00

——

a

4.O

ther

2025

.17

——

a3

28.0

9—

—a

1421

.56

——

a1

40.8

2—

—a

Don

’t kn

ow0

0.00

——

a1

8.93

——

a0

0.00

——

a0

0.00

——

a

No

answ

er1

0.38

——

a1

8.50

——

a4

8.79

——

a0

0.00

——

a

Mea

n ye

ars

afte

r ex

pira

tion

date

62.

20—

—a

11.

00—

—a

33.

97—

—a

—b

——

—

Mea

n ye

ars

from

dat

e of

man

ufac

ture

34.

18—

—a

23.

98—

—a

32.

86—

—a

—b

——

—

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.b C

ould

not

est

imat

e be

caus

e th

ere

wer

e no

res

pond

ents

for

that

que

stio

n.


E-12

Ta

ble

E-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.0

Are

raw

mat

eria

ls, i

n-pr

oces

sm

ater

ials

, or

finis

hed

prod

ucts

hand

led

or s

tore

d at

this

pla

nt o

rsi

te?

1.Y

es11

395

.84

87.1

298

.74

1610

0.00

100.

0010

0.00

9195

.14

89.3

097

.87

570

.88

30.4

293

.13

2.N

o (S

kip

to S

ectio

n 5)

54.

161.

2612

.88

00.

000.

000.

006

4.86

2.13

10.7

02

29.1

26.

8769

.58

4.1

Wha

t per

cent

age

of p

lant

s ar

ecl

assi

fied

as o

wne

d vs

. lea

sed?

c

(Incl

ude

war

ehou

se fa

cilit

ies

loca

ted

at th

is p

lant

.)

a.O

wne

d59

51.1

839

.58

62.6

59

55.2

130

.93

77.2

346

48.8

535

.67

62.1

94

83.7

236

.26

97.8

9

b.Le

ased

5448

.82

37.3

560

.42

744

.79

22.7

769

.07

4551

.15

37.8

164

.33

116

.28

2.11

63.7

4

Ow

ned

Faci

litie

s

4.2

Are

ther

e w

ritte

n pr

oced

ures

on

mai

nten

ance

of t

he g

roun

ds a

bout

the

plan

t?

1.Y

es36

58.2

741

.61

73.2

44

44.8

516

.82

76.5

815

38.1

821

.40

58.3

52

50.0

610

.83

89.2

2

2.N

o22

41.0

426

.14

57.7

95

55.1

523

.42

83.1

828

53.4

335

.42

70.5

92

49.9

410

.78

89.1

7

Not

app

licab

le0

0.00

0.00

0.00

00.

000.

000.

001

1.89

0.25

12.8

50

0.00

0.00

0.00

Don

’t kn

ow1

0.68

0.09

4.79

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

002

6.50

1.42

25.2

10

0.00

0.00

0.00

(con

tinue

d)


E-13

Ta

ble

E-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.3

Are

ther

e w

ritte

n pr

oced

ures

on

gene

ral m

aint

enan

ce a

nd s

anita

tion

of th

e bu

ildin

gs, f

ixtu

res,

and

oth

erph

ysic

al fa

cilit

ies

of th

e pl

ant?

1.Y

es49

80.5

264

.18

90.5

16

66.4

931

.36

89.6

127

65.3

949

.58

78.4

02

50.0

610

.83

89.2

2

2.N

o9

18.7

98.

9435

.30

333

.51

10.3

968

.64

1832

.72

20.0

148

.60

249

.94

10.7

889

.17

Not

app

licab

le1

0.68

0.09

4.79

00.

000.

000.

001

1.89

0.25

12.8

50

0.00

0.00

0.00

4.4

Are

ther

e w

ritte

n pr

oced

ures

on

the

stor

age

and

use

of c

lean

ing

and

sani

tizin

g m

ater

ials

?

1.Y

es44

71.8

354

.55

84.4

24

44.3

317

.17

75.3

624

60.2

844

.59

74.1

22

50.0

610

.83

89.2

2

2.N

o14

27.4

915

.01

44.8

75

55.6

724

.64

82.8

321

37.8

324

.20

53.6

92

49.9

410

.78

89.1

7

Not

app

licab

le1

0.68

0.09

4.79

00.

000.

000.

001

1.89

0.25

12.8

50

0.00

0.00

0.00

4.5

Are

ther

e w

ritte

n pr

oced

ures

on

pest

cont

rol?

1.Y

es47

78.3

061

.17

89.2

06

67.5

433

.45

89.5

927

63.9

747

.84

77.4

62

50.0

610

.83

89.2

2

2.N

o11

21.0

210

.25

38.2

73

32.4

610

.41

66.5

518

34.1

420

.94

50.3

62

49.9

410

.78

89.1

7

Not

app

licab

le1

0.68

0.09

4.79

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

1.89

0.25

12.8

50

0.00

0.00

0.00

(con

tinue

d)


E-14

Ta

ble

E-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.6

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at p

roce

dure

s fo

rbu

ildin

gs a

nd fa

cilit

ies

mai

nten

ance

are

bein

g fo

llow

ed?

1.Y

es45

78.7

863

.12

88.9

56

67.0

132

.30

89.6

421

53.1

336

.05

69.5

02

50.0

610

.83

89.2

2

2.N

o (S

kip

to S

ectio

n 5)

1421

.22

11.0

536

.88

332

.99

10.3

667

.70

2444

.98

28.9

762

.11

249

.94

10.7

889

.17

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

1.89

0.25

12.8

50

0.00

0.00

0.00

4.7

[If 4

.6 is

Yes

]A

re r

ecor

ds m

ade

of a

ny c

orre

ctiv

eac

tions

take

n if

proc

edur

es a

re n

otfo

llow

ed?

1.Y

es, f

or s

ome

proc

edur

es20

44.1

026

.86

62.9

04

66.1

524

.63

92.1

210

37.6

616

.91

64.2

11

59.1

87.

9396

.06

2.Y

es, f

or a

ll pr

oced

ures

1939

.53

23.3

858

.34

116

.93

1.96

67.5

35

22.8

47.

9050

.54

140

.82

3.94

92.0

7

3.N

o4

8.29

3.09

20.4

00

0.00

0.00

0.00

39.

492.

5929

.23

00.

000.

000.

00

No

answ

er2

8.08

1.64

31.7

01

16.9

31.

9667

.53

330

.01

7.73

68.6

90

0.00

0.00

0.00

Leas

ed F

acili

ties

4.8

Wha

t is

the

rem

aini

ng te

rm o

f the

leas

e? Yea

rs (m

ean

resp

onse

)49

3.64

——

a5

1.01

——

a42

4.39

——

a1

0.17

——

a

Ope

n le

ase

(%)

10.

790.

115.

552

27.9

66.

9566

.85

35.

181.

6215

.36

—b

——

—

(con

tinue

d)


E-15

Ta

ble

E-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.9

For

leas

ed fa

cilit

ies,

who

is p

rim

arily

resp

onsi

ble

for

mai

ntai

ning

the

grou

nds

abou

t the

pla

nt?

1.Pl

ant m

anag

emen

t (le

ssee

)30

47.5

430

.97

64.6

72

26.0

36.

3864

.50

1636

.74

20.0

857

.32

00.

000.

000.

00

2.Fa

cilit

y ow

ner

(less

or) (

Skip

toqu

estio

n 4.

11)

2347

.65

30.5

665

.30

573

.97

35.5

093

.62

2858

.77

38.7

476

.27

110

0.00

100.

0010

0.00

No

answ

er1

4.81

0.63

28.8

00

0.00

0.00

0.00

14.

480.

6226

.15

00.

000.

000.

00

4.10

[If

4.9

is 1

(les

see)

]Fo

r le

ased

faci

litie

s, a

re th

ere

wri

tten

proc

edur

es o

n m

aint

enan

ce o

f the

grou

nds

abou

t the

pla

nt?

1.Y

es12

32.8

613

.84

59.8

61

51.2

35.

6894

.82

423

.82

6.97

56.6

2—

b—

——

2.N

o17

66.0

339

.32

85.3

61

48.7

75.

1894

.32

940

.46

16.6

069

.87

—b

——

—

No

answ

er1

1.11

0.15

7.92

00.

000.

000.

003

35.7

29.

7274

.15

—b

——

—

(Ski

p to

que

stio

n 4.

12)

4.11

[If

4.9

is 2

(les

sor)

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

the

faci

lity

owne

ris

pro

perl

y m

aint

aini

ng th

e gr

ound

s?

1.Y

es7

30.0

811

.82

57.9

90

0.00

0.00

0.00

516

.49

6.15

37.3

40

0.00

0.00

0.00

2.N

o10

41.5

718

.65

68.8

33

56.7

019

.82

87.4

016

45.8

824

.73

68.6

21

100.

0010

0.00

100.

00

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

3.07

0.38

20.7

50

0.00

0.00

0.00

No

answ

er6

28.3

59.

7359

.22

243

.30

12.6

080

.18

634

.56

12.8

165

.48

00.

000.

000.

00

(con

tinue

d)


E-16

Ta

ble

E-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.12

For

leas

ed fa

cilit

ies,

who

ispr

imar

ily r

espo

nsib

le fo

r ge

nera

lm

aint

enan

ce a

nd s

anita

tion

of th

ebu

ildin

gs, f

ixtu

res,

and

oth

erph

ysic

al fa

cilit

ies

of th

e pl

ant?

1.Pl

ant m

anag

emen

t (le

ssee

)45

76.7

356

.78

89.2

26

86.0

240

.22

98.2

533

78.5

963

.24

88.6

80

0.00

0.00

0.00

2.Fa

cilit

y ow

ner

(less

or) (

Skip

toqu

estio

n 4.

15)

818

.46

7.69

38.0

91

13.9

81.

7559

.78

1221

.41

11.3

236

.76

110

0.00

100.

0010

0.00

No

answ

er1

4.81

0.63

28.8

00

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

4.13

[If

4.12

is 1

(les

see)

]Fo

r le

ased

faci

litie

s, a

re th

ere

wri

tten

proc

edur

es o

n ge

nera

l mai

nten

ance

and

sani

tatio

n of

the

build

ings

,fix

ture

s, a

nd o

ther

phy

sica

l fac

ilitie

sof

the

plan

t?

1.Y

es27

48.5

432

.12

65.2

91

14.7

61.

9060

.79

1965

.91

44.0

882

.59

—b

——

—

2.N

o17

50.7

734

.11

67.2

63

48.0

115

.89

81.8

611

27.9

813

.39

49.3

9—

b—

——

No

answ

er1

0.69

0.09

4.88

237

.23

9.47

77.0

93

6.11

1.75

19.2

0—

b—

——

4.14

[If

4.12

is 1

(les

see)

]Fo

r le

ased

faci

litie

s, a

re th

ere

wri

tten

proc

edur

es o

n th

e st

orag

e an

d us

eof

cle

anin

g an

d sa

nitiz

ing

mat

eria

ls?

1.Y

es26

47.9

729

.87

66.6

22

37.2

39.

4777

.09

1751

.10

28.6

673

.10

—b

——

—

2.N

o17

50.4

131

.94

68.7

63

48.0

115

.89

81.8

613

42.7

921

.82

66.7

2—

b—

——

No

answ

er2

1.62

0.39

6.51

114

.76

1.90

60.7

93

6.11

1.75

19.2

0—

b—

——

(Ski

p to

que

stio

n 4.

17)

(con

tinue

d)


E-17

Ta

ble

E-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.15

[If

4.12

is 2

(les

sor)

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

the

faci

lity

owne

ris

pro

perl

y m

aint

aini

ng th

ebu

ildin

gs, f

ixtu

res,

and

oth

erph

ysic

al fa

cilit

ies

of th

e pl

ant?

1.Y

es3

57.6

8—

—a

00.

00—

—a

328

.43

——

a0

0.00

——

a

2.N

o3

12.3

8—

—a

110

0.00

——

a8

63.1

4—

—a

110

0.00

——

a

Don

’t kn

ow0

0.00

——

a0

0.00

——

a0

0.00

——

a0

0.00

——

a

No

answ

er2

29.9

4—

—a

00.

00—

—a

18.

43—

—a

00.

00—

—a

4.16

[If

4.12

is 2

(les

sor)

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

the

clea

ning

and

sani

tizin

g m

ater

ials

use

d by

the

faci

lity

owne

r ar

e be

ing

prop

erly

stor

ed a

nd u

sed?

1.Y

es3

57.6

8—

—a

00.

00—

—a

436

.50

——

a0

0.00

——

a

2.N

o3

12.3

8—

—a

110

0.00

——

a7

55.0

7—

—a

110

0.00

——

a

Don

’t kn

ow0

0.00

——

a0

0.00

——

a0

0.00

——

a0

0.00

——

a

No

answ

er2

29.9

4—

—a

00.

00—

—a

18.

43—

—a

00.

00—

—a

(con

tinue

d)


E-18

Ta

ble

E-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.17

For

leas

ed fa

cilit

ies,

who

ispr

imar

ily r

espo

nsib

le fo

r pe

stco

ntro

l?

1.Pl

ant m

anag

emen

t (le

ssee

)45

73.7

854

.19

87.0

06

86.0

240

.22

98.2

531

74.2

457

.86

85.8

10

0.00

0.00

0.00

2.Fa

cilit

y ow

ner

(less

or) (

Skip

toqu

estio

n 4.

19)

821

.41

9.49

41.4

61

13.9

81.

7559

.78

1324

.04

12.9

740

.19

110

0.00

100.

0010

0.00

Not

app

licab

le0

0.00

0.00

0.00

00.

000.

000.

001

1.73

0.23

11.8

90

0.00

0.00

0.00

No

answ

er1

4.81

0.63

28.8

00

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

4.18

[If

4.17

is 1

(les

see)

]Fo

r le

ased

faci

litie

s, a

re th

ere

wri

tten

proc

edur

es o

n pe

st c

ontr

ol?

1.Y

es31

71.5

750

.67

86.0

53

53.4

917

.43

86.2

412

42.8

721

.91

66.7

5—

b—

——

2.N

o14

28.4

313

.95

49.3

33

46.5

113

.76

82.5

715

48.9

526

.64

71.6

9—

b—

——

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

004

8.18

2.72

22.1

3—

b—

——

(Ski

p to

que

stio

n 4.

20)

4.19

[If

4.17

is 2

(les

sor)

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

the

faci

lity

owne

ris

taki

ng p

rope

r pe

st c

ontr

olm

easu

res?

1.Y

es2

41.0

4—

—a

00.

00—

—a

430

.60

——

a0

0.00

——

a

2.N

o6

58.9

6—

—a

110

0.00

——

a5

36.5

7—

—a

110

0.00

——

a

Don

’t kn

ow0

0.00

——

a0

0.00

——

a1

7.19

——

a0

0.00

——

a

No

answ

er0

0.00

——

a0

0.00

——

a3

25.6

4—

—a

00.

00—

—a

(con

tinue

d)


E-19

Ta

ble

E-4

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

4: B

uild

ing

s a

nd

Fa

cilit

ies

(co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

4.20

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at p

roce

dure

s fo

rbu

ildin

gs a

nd fa

cilit

ies

mai

nten

ance

are

bein

g fo

llow

ed?

1.Y

es31

51.2

036

.05

66.1

34

59.3

423

.71

87.2

721

48.5

030

.10

67.3

30

0.00

0.00

0.00

2.N

o (S

kip

to S

ectio

n 5)

2034

.37

19.7

552

.70

340

.66

12.7

376

.29

2247

.96

29.5

166

.99

110

0.00

100.

0010

0.00

Not

app

licab

le0

0.00

0.00

0.00

00.

000.

000.

001

1.73

0.23

11.8

90

0.00

0.00

0.00

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

1.80

0.24

12.3

60

0.00

0.00

0.00

No

answ

er3

14.4

34.

9735

.22

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

00

4.21

[If

4.20

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es16

57.6

938

.78

74.5

82

43.8

69.

3685

.54

1143

.27

19.9

370

.04

—b

——

—

2.Y

es, f

or a

ll pr

oced

ures

511

.37

4.19

27.3

51

32.5

84.

5283

.13

636

.80

13.3

668

.74

—b

——

—

3.N

o7

22.1

49.

3743

.88

123

.56

2.90

76.0

63

16.3

74.

4145

.36

—b

——

—

No

answ

er3

8.80

2.57

26.1

00

0.00

0.00

0.00

13.

560.

4423

.75

—b

——

—

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.b C

ould

not

est

imat

e be

caus

e th

ere

wer

e no

res

pond

ents

for

that

que

stio

n.c I

f 50%

or

mor

e of

the

plan

t’s fa

cilit

ies

are

owne

d, th

e re

spon

dent

com

plet

ed q

uest

ions

4.2

thro

ugh

4.7.

If 5

0% o

r m

ore

of th

e pl

ant’s

faci

litie

s ar

e le

ased

, the

resp

onde

nt c

ompl

eted

que

stio

ns 4

.8 th

roug

h 4.

21.


E-20

Ta

ble

E-5

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

5: E

qu

ipm

en

t

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

5.0

Is e

quip

men

t at t

his

plan

t or

site

used

to p

roce

ss r

aw m

ater

ials

, in-

proc

ess

mat

eria

ls, o

r fin

ishe

dpr

oduc

ts?

1.Y

es11

092

.92

83.0

897

.23

1485

.08

55.6

096

.29

8589

.98

82.7

394

.40

682

.42

34.7

897

.63

2.N

o (S

kip

to S

ectio

n 6)

87.

082.

7716

.92

214

.92

3.71

44.4

012

10.0

25.

6017

.27

117

.58

2.37

65.2

2

5.1

Are

ther

e w

ritte

n pr

oced

ures

on

the

clea

ning

, san

itizi

ng, a

ndm

aint

aini

ng o

f equ

ipm

ent a

ndut

ensi

ls?

1.Y

es90

75.4

862

.98

84.7

710

71.5

743

.20

89.2

962

71.6

957

.33

82.6

73

50.0

415

.82

84.2

3

2.N

o (S

kip

to q

uest

ion

5.4)

2024

.52

15.2

337

.02

428

.43

10.7

156

.80

2328

.31

17.3

342

.67

349

.96

15.7

784

.18

5.2

[If 5

.1 is

Yes

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

thes

e pr

oced

ures

are

bein

g fo

llow

ed?

1.Y

es80

84.9

071

.29

92.7

29

90.1

953

.60

98.6

549

79.2

064

.76

88.7

52

72.0

118

.43

96.7

0

2.N

o (S

kip

to q

uest

ion

5.4)

914

.37

6.72

28.0

90

0.00

0.00

0.00

1219

.84

10.4

934

.32

127

.99

3.30

81.5

7

No

answ

er1

0.73

0.10

5.10

19.

811.

3546

.40

10.

960.

136.

740

0.00

0.00

0.00

(con

tinue

d)


E-21

Ta

ble

E-5

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

5: E

qu

ipm

en

t

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

5.3

[If 5

.2 is

Yes

]A

re r

ecor

ds m

ade

of a

ny c

orre

ctiv

eac

tions

take

n if

proc

edur

es a

re n

otfo

llow

ed?

1.Y

es, f

or s

ome

proc

edur

es30

34.6

722

.70

48.9

54

44.0

416

.86

75.3

322

39.1

123

.80

56.9

10

0.00

0.00

0.00

2.Y

es, f

or a

ll pr

oced

ures

3750

.16

36.8

263

.47

334

.21

11.1

968

.21

1837

.39

21.2

057

.00

210

0.00

100.

0010

0.00

3.N

o13

15.1

88.

2426

.28

111

.40

1.46

52.8

67

10.8

04.

8322

.43

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

110

.35

1.44

47.8

12

12.7

02.

4246

.01

00.

000.

000.

00

5.4

Doe

s th

is p

lant

val

idat

e th

ateq

uipm

ent,

inst

rum

ents

, and

cont

rols

are

inst

alle

d co

rrec

tly?

1.Y

es67

57.0

845

.33

68.0

811

79.2

751

.39

93.2

663

74.1

859

.58

84.8

43

57.3

621

.49

86.8

7

2.N

o38

39.1

128

.50

50.8

73

20.7

36.

7448

.61

2018

.61

11.7

228

.26

228

.63

6.77

68.9

2

No

answ

er5

3.81

1.53

9.14

00.

000.

000.

002

7.21

1.32

31.1

11

14.0

01.

8358

.68

5.5

Doe

s th

is p

lant

val

idat

e th

ateq

uipm

ent,

inst

rum

ents

, and

cont

rols

are

use

d co

rrec

tly?

1.Y

es78

65.5

953

.55

75.9

110

71.5

743

.20

89.2

967

72.4

555

.98

84.4

74

71.3

731

.08

93.2

3

2.N

o28

31.5

421

.58

43.5

54

28.4

310

.71

56.8

017

21.2

711

.29

36.4

42

28.6

36.

7768

.92

No

answ

er4

2.87

1.02

7.81

00.

000.

000.

001

6.28

0.91

32.9

30

0.00

0.00

0.00

(con

tinue

d)


E-22

Ta

ble

E-5

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

5: E

qu

ipm

en

t

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

5.6

Doe

s th

is p

lant

val

idat

e th

eeq

uipm

ent u

sed

in q

ualit

y co

ntro

l?Q

ualit

y co

ntro

l equ

ipm

ent i

nclu

des

auto

mat

ic, m

echa

nica

l, el

ectr

onic

,an

d co

mpu

ter

equi

pmen

t, in

clud

ing

hard

war

e an

d so

ftwar

e.

1.Y

es77

65.5

253

.07

76.1

69

64.8

937

.65

84.9

858

68.0

353

.62

79.6

73

57.3

621

.49

86.8

7

2.N

o28

29.1

819

.25

41.6

04

28.4

310

.71

56.8

021

20.7

313

.18

31.0

62

28.6

36.

7768

.92

No

answ

er5

5.30

1.80

14.5

71

6.68

0.93

35.2

96

11.2

33.

6229

.87

114

.00

1.83

58.6

8


E-23

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.1

Is th

ere

a un

it or

per

son

resp

onsi

ble

for

qual

ity c

ontr

ol?

1.Y

es10

684

.50

72.9

191

.70

1276

.10

50.6

390

.82

8286

.81

78.3

892

.27

570

.88

30.4

293

.13

2.N

o (S

kip

to q

uest

ion

6.4)

810

.29

4.54

21.6

94

23.9

09.

1849

.37

33.

441.

1010

.27

111

.54

1.53

52.2

2

Not

app

licab

le (S

kip

to q

uest

ion

6.4)

32.

960.

6212

.89

00.

000.

000.

006

5.12

2.26

11.1

71

17.5

82.

3765

.22

No

answ

er1

2.25

0.31

14.7

10

0.00

0.00

0.00

64.

642.

0210

.29

00.

000.

000.

00

6.2

[If 6

.1 is

Yes

]A

re th

ere

wri

tten

proc

edur

es o

n th

ere

spon

sibi

litie

s an

d pr

oced

ures

requ

ired

of t

he q

ualit

y co

ntro

lun

it/pe

rson

?

1.Y

es86

84.3

973

.75

91.2

39

72.1

640

.22

90.9

054

67.4

352

.82

79.2

92

41.9

010

.00

82.4

0

2.N

o15

12.2

66.

1822

.87

18.

231.

0742

.62

2529

.58

18.0

744

.44

241

.81

9.96

82.3

5

No

answ

er5

3.35

1.26

8.60

219

.61

4.89

53.6

33

2.99

0.94

9.07

116

.28

2.11

63.7

4

(con

tinue

d)


E-24

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.3*

[If 6

.1 is

Yes

]Fo

r w

hich

of t

he fo

llow

ing

does

the

qual

ity c

ontr

ol u

nit/p

erso

n ha

vere

spon

sibi

lity

and

auth

ority

?

1.A

ppro

val/r

ejec

tion

of c

lean

ing

and

mai

nten

ance

pro

cedu

res

7570

.63

58.4

980

.41

972

.16

40.2

290

.90

6070

.62

56.1

081

.89

475

.20

24.1

696

.65

2.A

ppro

val/r

ejec

tion

ofpr

oced

ures

, spe

cific

atio

ns,

cont

rols

, tes

ts, a

nd e

xam

inat

ions

for

puri

ty, q

ualit

y, a

ndco

mpo

sitio

n

8886

.60

77.2

492

.48

1080

.39

46.3

795

.11

7391

.11

83.2

795

.47

482

.99

35.0

497

.78

3.A

ppro

val/r

ejec

tion

of r

awm

ater

ials

8881

.59

69.7

989

.47

1188

.62

50.5

498

.34

7482

.17

62.3

992

.76

482

.99

35.0

497

.78

4.A

ppro

val/r

ejec

tion

of p

acka

ging

mat

eria

ls83

73.3

760

.77

83.0

411

88.6

250

.54

98.3

466

75.2

960

.45

85.8

65

100.

0010

0.00

100.

00

5.A

ppro

val/r

ejec

tion

of la

belin

g82

76.2

164

.37

85.0

311

91.7

757

.38

98.9

366

76.8

462

.16

87.0

13

58.9

218

.05

90.3

3

6.A

ppro

val/r

ejec

tion

of fi

nish

eddi

etar

y pr

oduc

ts92

86.4

275

.92

92.7

711

91.7

757

.38

98.9

367

83.6

773

.04

90.6

54

83.7

236

.26

97.8

9

7.O

ther

63.

691.

568.

470

0.00

0.00

0.00

33.

040.

998.

931

24.8

03.

3575

.84

No

answ

er7

5.41

2.44

11.5

60

0.00

0.00

0.00

21.

980.

487.

830

0.00

0.00

0.00

(con

tinue

d)


E-25

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.4

Doe

s th

is p

lant

req

uire

sup

plie

rs to

prov

ide

a C

ertif

icat

e of

Ana

lysi

s?

1.Y

es, f

rom

som

e su

pplie

rs22

17.6

710

.39

28.4

25

29.5

812

.82

54.5

544

41.9

130

.04

54.8

02

29.1

26.

8769

.58

2.Y

es, f

rom

all

supp

liers

8370

.67

58.9

380

.19

955

.49

31.6

677

.04

3033

.66

22.9

046

.42

341

.76

13.1

477

.26

3.N

o, d

o no

t req

uire

Cof

A fr

oman

y su

pplie

rs (S

kip

toqu

estio

n 6.

7)

32.

940.

6112

.90

16.

260.

8334

.72

1310

.89

6.14

18.5

70

0.00

0.00

0.00

4.D

o no

t rec

eive

ingr

edie

nts

(Ski

pto

que

stio

n 6.

7)7

5.27

1.95

13.4

30

0.00

0.00

0.00

26.

931.

3828

.32

111

.54

1.53

52.2

2

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

002

1.72

0.42

6.80

00.

000.

000.

00

No

answ

er3

3.46

0.84

13.0

81

8.66

1.25

41.5

86

4.90

2.14

10.8

01

17.5

82.

3765

.22

6.5

[If 6

.4 is

Yes

]D

oes

this

pla

nt v

erify

the

relia

bilit

yof

the

supp

liers

’ Cer

tific

ate

ofA

naly

sis?

1.Y

es78

76.8

765

.09

85.5

510

72.2

544

.68

89.3

550

73.1

161

.11

82.4

73

66.7

025

.15

92.2

8

2.N

o (S

kip

to q

uest

ion

6.7)

2622

.85

14.2

034

.65

427

.75

10.6

555

.32

2326

.07

16.8

937

.97

233

.30

7.72

74.8

5

No

answ

er1

0.28

0.04

1.98

00.

000.

000.

001

0.82

0.11

5.74

00.

000.

000.

00

(con

tinue

d)


E-26

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.6*

[If 6

.5 is

Yes

]H

ow is

rel

iabi

lity

of th

e su

pplie

rs’

Cer

tific

ate

of A

naly

sis

veri

fied?

1.C

ondu

ct o

n-si

te r

evie

w o

fsu

pplie

rs’ o

pera

tions

3944

.79

31.5

158

.85

330

.09

9.46

63.9

518

39.0

722

.89

58.0

82

62.8

211

.47

95.6

6

2.Pe

rfor

m te

sts

in-h

ouse

to c

onfir

mre

sults

4654

.50

40.6

167

.73

769

.91

36.0

590

.54

2655

.00

36.9

271

.85

00.

000.

000.

00

3.U

se o

ff-si

te la

bora

tory

to c

onfir

mre

sults

5266

.75

52.5

278

.47

770

.84

38.0

490

.58

3770

.99

51.1

085

.14

310

0.00

100.

0010

0.00

4.R

equi

re s

uppl

iers

to c

ondu

ctte

sts

as p

art o

f sup

ply

spec

ifica

tions

3246

.77

33.4

560

.57

220

.37

4.88

56.0

719

42.8

725

.47

62.2

31

37.1

84.

3488

.53

5.St

anda

rd r

efer

ence

mat

eria

ls32

38.4

325

.81

52.8

12

20.3

74.

8856

.07

1930

.46

18.0

146

.63

125

.64

3.14

78.5

8

6.O

ther

55.

091.

6614

.55

00.

000.

000.

001

8.45

1.22

40.9

20

0.00

0.00

0.00

No

answ

er1

1.28

0.17

8.77

00.

000.

000.

002

3.04

0.74

11.6

70

0.00

0.00

0.00

6.7*

Doe

s th

is p

lant

con

duct

test

s on

any

raw

mat

eria

ls?

1.Y

es, i

n-ho

use

6753

.90

42.5

564

.86

1061

.18

36.1

281

.46

5352

.06

39.3

664

.50

346

.70

15.7

080

.47

2.Y

es, o

ff-si

te68

56.9

145

.32

67.8

04

24.4

79.

2950

.63

4543

.31

31.2

356

.23

341

.24

12.8

576

.97

3.N

o (S

kip

to q

uest

ion

6.14

)16

13.2

67.

0123

.67

211

.95

3.15

36.1

816

19.3

510

.27

33.4

72

23.6

05.

6761

.38

Not

app

licab

le (S

kip

to q

uest

ion

6.14

)2

2.59

0.45

13.5

71

8.66

1.25

41.5

84

3.40

1.25

8.90

00.

000.

000.

00

No

answ

er2

3.12

0.67

13.4

11

6.26

0.83

34.7

26

4.67

2.04

10.3

71

17.5

82.

3765

.22

(con

tinue

d)


E-27

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.8

[If 6

.7 is

Yes

]W

hat p

erce

ntag

e of

raw

mat

eria

lsar

e sa

mpl

ed a

nd te

sted

? (P

rovi

deav

erag

e fo

r al

l raw

mat

eria

ls.)

% o

f lot

s (m

ean

resp

onse

)98

68.5

258

.25

78.8

012

77.8

161

.56

94.0

665

64.0

451

.27

76.8

23

36.6

60.

00b

80.0

8

6.9*

[If

6.7

is Y

es]

Whi

ch o

f the

follo

win

g te

stin

gte

chni

ques

are

use

d to

con

firm

iden

tity

of in

gred

ient

s fo

r ra

wm

ater

ials

?

1.Ph

ysic

al88

89.3

678

.48

95.0

810

83.2

751

.35

95.9

156

71.7

452

.91

85.1

52

59.7

617

.66

91.1

4

2.C

hem

ical

8185

.47

75.0

392

.01

975

.49

45.0

992

.04

3046

.91

32.5

861

.77

250

.50

11.4

788

.93

3.M

icro

biol

ogic

al55

59.8

647

.27

71.2

75

42.0

318

.21

70.2

428

49.8

135

.67

63.9

82

40.2

48.

8682

.34

4.V

isua

l (m

acro

scop

ic o

rm

icro

scop

ic)

6669

.91

58.1

579

.52

975

.10

43.8

892

.08

5777

.67

60.0

888

.93

249

.50

11.0

788

.53

5.O

rgan

olep

tic52

49.3

336

.94

61.7

93

24.9

07.

9256

.12

4257

.78

42.5

371

.67

129

.88

3.92

81.6

4

6.N

o te

sts

are

cond

ucte

d to

conf

irm

iden

tity

of in

gred

ient

s1

2.78

0.37

17.8

40

0.00

0.00

0.00

11.

220.

178.

280

0.00

0.00

0.00

7.O

ther

65.

481.

7615

.77

17.

781.

0839

.36

66.

742.

8615

.09

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

0.85

0.12

5.98

00.

000.

000.

00

(con

tinue

d)


E-28

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.10

* [

If 6.

7 is

Yes

]W

hich

of t

he fo

llow

ing

test

ing

tech

niqu

es a

re u

sed

for

dete

ctin

gco

ntam

inat

ion

of r

aw m

ater

ials

?

1.Ph

ysic

al69

71.1

459

.13

80.7

810

83.6

651

.83

96.0

643

51.9

737

.20

66.4

13

80.3

829

.77

97.5

4

2.C

hem

ical

5758

.33

45.6

370

.01

759

.15

31.2

582

.19

2639

.57

25.8

655

.15

120

.61

2.61

71.5

3

3.M

icro

biol

ogic

al74

71.8

958

.67

82.1

68

67.3

237

.65

87.5

443

68.8

856

.60

78.9

83

70.1

218

.36

96.0

8

4.V

isua

l (m

acro

scop

ic o

rm

icro

scop

ic)

7073

.56

61.7

582

.74

867

.32

37.6

587

.54

5574

.75

57.6

286

.57

249

.50

11.0

788

.53

5.O

rgan

olep

tic39

39.4

727

.83

52.4

31

7.78

1.08

39.3

639

54.8

739

.93

68.9

81

20.6

12.

6171

.53

6.N

o te

sts

are

cond

ucte

d to

det

ect

cont

amin

atio

n3

3.97

0.91

15.7

10

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

7.O

ther

31.

320.

443.

911

7.78

1.08

39.3

62

2.37

0.57

9.31

00.

000.

000.

00

No

answ

er1

1.07

0.15

7.38

00.

000.

000.

001

0.85

0.12

5.98

00.

000.

000.

00

6.11

[If

6.7

is Y

es]

Doe

s th

is p

lant

con

duct

che

mic

alte

sts

to d

eter

min

e po

tenc

y of

raw

mat

eria

ls?

1.Y

es71

72.1

759

.45

82.1

08

67.7

238

.99

87.3

229

38.4

125

.94

52.6

11

29.8

83.

9281

.64

2.N

o26

26.7

616

.99

39.4

74

32.2

812

.68

61.0

139

51.8

037

.23

66.0

73

70.1

218

.36

96.0

8

No

answ

er1

1.07

0.15

7.38

00.

000.

000.

003

9.79

2.12

35.2

90

0.00

0.00

0.00

(con

tinue

d)


E-29

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.12

[If

6.7

is Y

es]

For

the

mos

t rec

ent f

isca

l yea

r,ap

prox

imat

ely

wha

t per

cent

age

ofra

w m

ater

ials

was

rej

ecte

d be

caus

eof

the

wro

ng id

entit

y,co

ntam

inat

ion,

or

pote

ncy?

% o

f lot

s (m

ean

resp

onse

)98

3.08

1.79

4.37

121.

520.

00b

3.12

664.

302.

396.

214

0.21

0.00

b0.

58

6.13

[If

6.12

> 0

]W

hat w

as th

e re

ason

(s) f

or th

ere

ject

ion?

(mea

n re

spon

se in

%)

1.M

icro

bial

con

tam

inat

ion

6534

.76

24.3

745

.15

747

.77

11.4

284

.11

4820

.78

10.3

131

.26

110

0.00

100.

0010

0.00

2.Pe

stic

ide,

her

bici

de, f

ungi

cide

cont

amin

atio

n65

0.84

0.00

b1.

897

7.24

0.00

b21

.11

483.

130.

335.

941

0.00

0.00

0.00

3.O

ther

che

mic

al c

onta

min

atio

n65

4.94

1.03

8.85

714

.48

0.00

b42

.21

481.

160.

00b

2.65

10.

000.

000.

00

4.W

rong

ingr

edie

nt65

14.0

37.

6020

.47

70.

000.

000.

0048

25.1

313

.71

36.5

71

0.00

0.00

0.00

5.Su

bpot

ency

6523

.11

13.2

632

.96

730

.52

2.11

58.9

248

25.8

615

.84

35.8

81

0.00

0.00

0.00

6.Su

perp

oten

cy65

1.52

0.06

2.98

70.

000.

000.

0048

2.14

0.00

b5.

641

0.00

0.00

0.00

7.A

flato

xin

or o

ther

toxi

n65

0.85

0.00

b2.

307

0.00

0.00

0.00

481.

160.

00b

2.68

10.

000.

000.

00

8.O

ther

6519

.93

12.2

327

.64

70.

000.

000.

0048

20.6

28.

3832

.86

10.

000.

000.

00

(con

tinue

d)


E-30

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.14

Doe

s th

is p

lant

con

duct

test

s on

any

in-p

roce

ss m

ater

ials

and

/or

finis

hed

prod

ucts

?

1.Y

es92

75.0

163

.15

84.0

212

75.8

249

.43

90.9

654

54.0

641

.20

66.4

04

58.8

223

.07

87.1

9

2.N

o (S

kip

to q

uest

ion

6.21

)22

19.8

111

.87

31.2

04

24.1

89.

0450

.57

3236

.33

24.4

350

.17

223

.60

5.67

61.3

8

Not

app

licab

le (S

kip

toqu

estio

n 6.

21)

32.

920.

6112

.91

00.

000.

000.

006

5.52

2.40

12.1

90

0.00

0.00

0.00

No

answ

er1

2.25

0.31

14.7

10

0.00

0.00

0.00

54.

091.

679.

681

17.5

82.

3765

.22

6.15

[If

6.14

is Y

es]

Wha

t per

cent

age

of in

-pro

cess

mat

eria

ls a

nd/o

r fin

ishe

d pr

oduc

tsar

e sa

mpl

ed a

nd te

sted

?

In-p

roce

ss m

ater

ials

: %

of b

atch

es(m

ean

resp

onse

)91

55.3

843

.74

67.0

212

58.3

034

.93

81.6

752

60.0

645

.21

74.9

14

73.1

128

.75

117.

46

Fini

shed

pro

duct

s: %

of b

atch

es(m

ean

resp

onse

)91

64.5

253

.18

75.8

512

86.9

569

.90

100.

00c

5266

.02

52.7

079

.33

443

.22

0.00

b87

.63

(con

tinue

d)


E-31

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.16

* [

If 6.

14 is

Yes

]W

hich

of t

he fo

llow

ing

test

ing

tech

niqu

es a

re u

sed

to c

onfir

mid

entit

y of

ingr

edie

nts

for

in-p

roce

ssm

ater

ials

and

/or

finis

hed

prod

ucts

?

1.Ph

ysic

al70

80.9

571

.76

87.6

79

75.6

044

.41

92.3

236

60.9

043

.47

75.9

32

59.7

617

.68

91.1

3

2.C

hem

ical

6572

.29

59.1

382

.47

972

.44

40.7

590

.94

2245

.06

30.2

360

.82

120

.61

2.61

71.5

4

3.M

icro

biol

ogic

al34

39.5

127

.59

52.8

26

48.4

222

.47

75.2

518

38.6

323

.80

55.9

22

40.2

48.

8782

.32

4.V

isua

l (m

acro

scop

ic o

rm

icro

scop

ic)

5862

.92

49.6

374

.51

759

.84

31.0

883

.12

3868

.78

53.3

280

.95

370

.12

18.2

696

.10

5.O

rgan

olep

tic40

45.3

032

.69

58.5

42

19.6

84.

8953

.88

3259

.17

43.4

773

.21

250

.50

11.4

088

.99

6.N

o te

sts

are

cond

ucte

d to

conf

irm

iden

tity

of in

gred

ient

s1

0.33

0.05

2.33

17.

881.

0840

.03

23.

190.

7712

.22

00.

000.

000.

00

7.O

ther

87.

182.

7017

.71

00.

000.

000.

003

5.55

1.68

16.7

81

29.8

83.

9081

.74

No

answ

er1

1.16

0.16

7.95

00.

000.

000.

003

7.15

2.03

22.2

50

0.00

0.00

0.00

(con

tinue

d)


E-32

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.17

* [

If 6.

14 is

Yes

]W

hich

of t

he fo

llow

ing

test

ing

tech

niqu

es a

re u

sed

for

dete

ctin

gco

ntam

inat

ion

of in

-pro

cess

mat

eria

ls a

nd/o

r fin

ishe

d pr

oduc

ts?

1.Ph

ysic

al51

57.4

844

.78

69.2

78

67.7

238

.28

87.6

533

55.4

339

.02

70.7

42

59.7

617

.68

91.1

3

2.C

hem

ical

4245

.27

32.8

258

.34

756

.68

28.6

281

.02

1829

.28

17.8

344

.14

250

.50

11.4

088

.99

3.M

icro

biol

ogic

al66

74.1

261

.60

83.6

56

48.4

222

.47

75.2

532

63.4

248

.94

75.8

32

40.2

48.

8782

.32

4.V

isua

l (m

acro

scop

ic o

rm

icro

scop

ic)

5159

.71

46.5

971

.57

759

.84

31.0

883

.12

3769

.57

54.4

181

.41

370

.12

18.2

696

.10

5.O

rgan

olep

tic31

37.1

825

.37

50.7

51

11.4

21.

6549

.72

3056

.34

40.5

670

.92

00.

000.

000.

00

6.N

o te

sts

are

cond

ucte

d to

det

ect

cont

amin

atio

n4

3.60

1.29

9.66

18.

261.

0742

.83

23.

190.

7712

.22

00.

000.

000.

00

7.O

ther

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

No

answ

er1

1.16

0.16

7.95

00.

000.

000.

004

8.77

2.94

23.3

70

0.00

0.00

0.00

6.18

[If

6.14

is Y

es]

Doe

s th

is p

lant

con

duct

che

mic

alte

sts

to d

eter

min

e po

tenc

y of

in-

proc

ess

mat

eria

ls a

nd/o

r fin

ishe

dpr

oduc

ts?

1.Y

es68

78.1

465

.95

86.8

38

65.3

237

.76

85.3

927

53.1

737

.69

68.0

62

50.5

011

.40

88.9

9

2.N

o23

20.7

012

.24

32.8

24

34.6

814

.61

62.2

424

39.6

926

.23

54.9

12

49.5

011

.01

88.6

0

No

answ

er1

1.16

0.16

7.95

00.

000.

000.

003

7.15

2.03

22.2

50

0.00

0.00

0.00

(con

tinue

d)


E-33

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.19

[If

6.14

is Y

es]

For

the

mos

t rec

ent f

isca

l yea

r,ap

prox

imat

ely

wha

t per

cent

age

ofin

-pro

cess

mat

eria

ls a

nd/o

r fin

ishe

dpr

oduc

ts w

as r

ejec

ted

beca

use

ofth

e w

rong

iden

tity,

con

tam

inat

ion,

or p

oten

cy?

In-p

roce

ss m

ater

ials

: %

of

batc

hes

(mea

n re

spon

se)

711.

570.

542.

599

13.8

9d0.

00b

35.2

741

1.37

0.78

1.95

40.

500.

00b

1.03

Fini

shed

pro

duct

s: %

of b

atch

es(m

ean

resp

onse

)77

3.81

0.77

6.86

129.

82d

0.00

b25

.72

463.

230.

00b

6.71

30.

290.

00b

0.80

6.20

[If

6.19

> 0

]W

hat w

as th

e re

ason

(s) f

or th

ere

ject

ion?

In-P

roce

ss M

ater

ials

(mea

nre

spon

ses

in %

)

1.M

icro

bial

con

tam

inat

ion

3413

.72

0.00

b28

.58

538

.24

5.21

71.2

823

35.7

05.

9265

.49

240

.82

0.00

b10

0.00

c

2.Pe

stic

ide,

her

bici

de, f

ungi

cide

cont

amin

atio

n34

0.08

0.00

b0.

235

0.00

0.00

0.00

230.

000.

000.

002

0.00

0.00

0.00

3.O

ther

che

mic

al c

onta

min

atio

n34

5.11

0.00

b10

.98

536

.67

0.00

b80

.54

230.

270.

00b

0.80

20.

000.

000.

00

4.W

rong

ingr

edie

nt34

13.6

71.

1426

.20

51.

850.

00b

4.96

2312

.07

0.06

24.0

82

0.00

0.00

0.00

5.Su

bpot

ency

3418

.16

9.29

27.0

35

4.63

0.00

b12

.41

2324

.64

6.27

43.0

22

59.1

80.

00b

100.

00c

6.Su

perp

oten

cy34

4.03

0.79

7.28

50.

000.

000.

0023

0.72

0.00

b2.

182

0.00

0.00

0.00

7.Fo

rmul

atio

n w

ith m

issi

ngin

gred

ient

348.

742.

5414

.93

54.

720.

00b

10.8

823

10.4

40.

00b

21.7

82

0.00

0.00

0.00

8.A

flato

xin

or o

ther

toxi

n34

0.00

0.00

0.00

50.

000.

000.

0023

1.80

0.00

b5.

452

0.00

0.00

0.00

9.O

ther

3436

.50

20.5

752

.43

513

.89

0.00

b33

.78

2314

.35

0.00

b29

.11

20.

000.

000.

00

(con

tinue

d)


E-34

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.20

(co

ntin

ued)

Fini

shed

Pro

duct

s (m

ean

resp

onse

sin

%)

1.M

icro

bial

con

tam

inat

ion

4710

.26

2.65

17.8

86

27.8

20.

00b

57.3

124

41.9

418

.12

65.7

61

0.00

0.00

0.00

2.Pe

stic

ide,

her

bici

de, f

ungi

cide

cont

amin

atio

n47

0.25

0.00

b0.

756

0.00

0.00

0.00

240.

790.

00b

2.40

10.

000.

000.

00

3.O

ther

che

mic

al c

onta

min

atio

n47

3.48

0.00

b7.

326

14.6

20.

00b

42.4

624

1.03

0.00

b2.

721

0.00

0.00

0.00

4.W

rong

ingr

edie

nt47

13.5

74.

5522

.60

619

.75

0.00

b47

.65

244.

610.

00b

10.4

51

100.

0010

0.00

100.

00

5.Su

bpot

ency

4721

.99

10.0

833

.90

69.

380.

00b

26.4

424

32.2

39.

7954

.67

10.

000.

000.

00

6.Su

perp

oten

cy47

5.15

0.72

9.57

60.

000.

000.

0024

0.00

0.00

0.00

10.

000.

000.

00

7.Fo

rmul

atio

n w

ith m

issi

ngin

gred

ient

472.

740.

245.

246

8.08

0.96

15.2

024

0.00

0.00

0.00

10.

000.

000.

00

8.A

flato

xin

or o

ther

toxi

n47

0.00

0.00

0.00

60.

000.

000.

0024

0.00

0.00

0.00

10.

000.

000.

00

9.O

ther

4742

.56

28.2

256

.89

620

.35

0.00

b46

.18

2419

.40

2.86

35.9

31

0.00

0.00

0.00

(con

tinue

d)


E-35

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.21

* W

hich

of t

he fo

llow

ing

test

ing

met

hods

are

gen

eral

ly u

sed

for

test

ing

of r

aw m

ater

ials

, in-

proc

ess

mat

eria

ls, o

r fin

ishe

d pr

oduc

ts?

1.A

ssoc

iatio

n of

Ana

lytic

alC

hem

ists

(AO

AC

)56

45.2

334

.12

56.8

39

55.2

130

.95

77.2

230

33.0

722

.33

45.9

13

41.2

412

.85

76.9

7

2.U

.S. P

harm

acop

eia

(USP

)78

69.5

758

.15

79.0

010

61.1

836

.12

81.4

624

21.8

614

.09

32.3

01

17.5

82.

3765

.22

3.Fo

od C

hem

ical

CO

DEX

(FC

C)

4338

.97

28.3

150

.79

955

.49

31.6

677

.04

810

.06

4.75

20.0

71

17.5

82.

3765

.22

4.A

mer

ican

Che

mic

al S

ocie

ty(A

CS)

2015

.22

8.93

24.7

33

18.7

96.

1245

.06

55.

321.

9613

.63

00.

000.

000.

00

5.In

-hou

se m

etho

ds67

53.9

242

.30

65.1

210

63.5

838

.22

83.1

242

40.5

529

.06

53.1

81

17.5

82.

3765

.22

6.O

ther

1812

.16

6.78

20.8

53

17.6

45.

6943

.18

2935

.46

23.4

649

.62

223

.67

5.68

61.4

7

7.N

o te

stin

g co

nduc

ted

(Ski

p to

que

stio

n 6.

24)

108.

733.

8918

.46

15.

970.

8232

.74

1618

.81

9.83

32.9

91

11.5

41.

5352

.22

Don

’t kn

ow1

1.86

0.26

12.0

70

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

No

answ

er2

2.59

——

e0

0.00

——

e7

6.21

——

e2

29.6

4—

—e

6.22

[If

6.2

is 1

-6]

Doe

s yo

ur te

stin

g po

licy

spec

ify th

eus

e of

sta

ndar

d re

fere

nce

mat

eria

ls?

1.Y

es82

69.0

256

.29

79.4

08

52.3

628

.04

75.6

144

53.1

039

.52

66.2

32

33.5

87.

8874

.92

2.N

o (S

kip

to q

uest

ion

6.24

)17

20.0

111

.56

32.3

86

40.9

819

.62

66.3

927

35.2

623

.02

49.7

92

33.5

07.

8574

.87

Don

’t kn

ow2

0.77

0.19

3.07

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

00

No

answ

er7

10.2

04.

4021

.87

16.

660.

8836

.48

1011

.64

5.88

21.7

62

32.9

27.

6474

.45

(con

tinue

d)


E-36

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.23

* [

If 6.

22 is

Yes

]W

hat i

s th

e so

urce

of t

he s

tand

ard

refe

renc

e m

ater

ials

?

1.C

ompe

ndia

l ref

eren

ce s

tand

ard

6483

.30

71.5

090

.85

675

.73

37.5

094

.19

1847

.12

30.2

964

.64

159

.18

8.11

95.9

7

2.In

-hou

se p

rim

ary

refe

renc

em

ater

ials

3950

.20

36.3

963

.98

449

.12

18.9

679

.93

2957

.13

38.9

273

.59

159

.18

8.11

95.9

7

3.In

-hou

se w

orki

ng r

efer

ence

mat

eria

ls42

46.3

933

.33

59.9

84

49.1

218

.96

79.9

324

49.4

832

.00

67.0

91

59.1

88.

1195

.97

4.O

ther

107.

974.

1014

.94

00.

000.

000.

002

4.07

1.01

14.9

70

0.00

0.00

0.00

No

answ

er1

3.57

0.47

22.4

20

0.00

0.00

0.00

27.

011.

5426

.62

140

.82

4.03

91.8

9

6.24

Doe

s yo

ur p

lant

hol

dre

pres

enta

tive

rese

rve

sam

ples

of

each

bat

ch m

anuf

actu

red?

1.Y

es95

77.4

165

.74

85.9

513

82.0

855

.92

94.3

068

70.1

556

.97

80.6

63

41.7

613

.14

77.2

6

2.N

o (S

kip

to q

uest

ion

6.26

)14

14.3

57.

5725

.53

317

.92

5.70

44.0

818

20.2

411

.06

34.1

23

40.6

612

.63

76.4

6

Not

app

licab

le (S

kip

to q

uest

ion

6.26

)3

2.92

0.61

12.9

10

0.00

0.00

0.00

54.

681.

8811

.20

00.

000.

000.

00

No

answ

er6

5.32

1.94

13.7

50

0.00

0.00

0.00

64.

932.

1710

.84

117

.58

2.37

65.2

2

(con

tinue

d)


E-37

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.25

[If

6.24

is Y

es]

How

long

do

you

hold

repr

esen

tativ

e re

serv

e sa

mpl

es?

1.__

__ y

ear(

s) a

fter

expi

ratio

n da

te42

45.7

633

.29

58.7

92

14.5

63.

5044

.45

1922

.84

14.0

034

.98

270

.97

17.6

996

.53

2.__

__ y

ear(

s) fr

om d

ate

ofm

anuf

actu

re42

42.3

30.3

455

.24

862

.55

34.8

283

.93

3659

.47

45.1

672

.33

129

.03

3.47

82.3

1

3.O

ther

97.

93.

2418

.01

215

.26

3.70

45.7

410

13.4

86.

8124

.93

00.

000.

000.

00

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

1.83

0.25

12.1

90

0.00

0.00

0.00

No

answ

er2

4.03

0.85

17.0

61

7.63

1.00

40.4

12

2.40

0.59

9.28

00.

000.

000.

00

Mea

n ye

ars

afte

r ex

pira

tion

date

421.

991.

402.

592

3.86

0.00

b8.

0919

1.98

1.52

2.44

24.

660.

00b

10.8

1

Mea

n ye

ars

from

dat

e of

man

ufac

ture

424.

523.

815.

228

3.70

2.44

4.96

364.

043.

404.

681

6.00

6.00

6.00

6.26

Are

ther

e w

ritte

n pr

oced

ures

for

labo

rato

ry o

pera

tions

?

1.Y

es71

52.6

741

.69

63.4

19

54.9

230

.74

76.9

840

42.7

030

.98

55.2

92

29.7

07.

1169

.99

2.N

o (S

kip

to q

uest

ion

6.31

)11

11.6

65.

7022

.35

317

.92

5.70

44.0

817

14.1

18.

6722

.14

00.

000.

000.

00

3.D

o no

t hav

e la

bora

tory

oper

atio

ns (S

kip

to S

ectio

n 7)

3131

.28

21.4

243

.19

320

.90

6.80

48.9

034

37.8

225

.83

51.5

14

52.7

219

.26

83.9

1

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

1.28

0.18

8.71

00.

000.

000.

00

No

answ

er5

4.39

1.38

13.0

41

6.26

0.83

34.7

25

4.09

1.67

9.68

117

.58

2.37

65.2

2

(con

tinue

d)


E-38

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.27

[If

6.26

is Y

es]

Doe

s pl

ant m

anag

emen

t ver

ify a

ndke

ep r

ecor

ds th

at th

ese

proc

edur

esar

e be

ing

follo

wed

?

1.Y

es67

94.0

884

.91

97.8

27

77.7

240

.58

94.6

933

78.8

259

.24

90.5

02

100.

0010

0.00

100.

00

2.N

o (S

kip

to q

uest

ion

6.29

)3

4.27

1.32

12.9

22

22.2

85.

3159

.42

616

.07

6.57

34.2

70

0.00

0.00

0.00

No

answ

er1

1.65

0.22

11.1

30

0.00

0.00

0.00

15.

110.

7128

.77

00.

000.

000.

00

6.28

[If

6.27

is Y

es]

Are

rec

ords

mad

e of

any

cor

rect

ive

actio

ns ta

ken

if pr

oced

ures

are

not

follo

wed

?

1.Y

es, f

or s

ome

proc

edur

es25

36.1

422

.79

52.0

54

55.9

921

.28

85.6

918

62.4

343

.67

78.0

81

59.1

88.

0696

.00

2.Y

es, f

or a

ll pr

oced

ures

3656

.18

40.8

270

.44

344

.01

14.3

178

.72

1127

.34

14.4

945

.53

140

.82

4.00

91.9

4

3.N

o6

7.67

3.26

17.0

30

0.00

0.00

0.00

410

.23

3.62

25.7

10

0.00

0.00

0.00

(con

tinue

d)


E-39

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.29

* [

If 6.

26 is

Yes

]D

o yo

ur w

ritte

n pr

oced

ures

for

labo

rato

ry o

pera

tions

incl

ude

any

ofth

e fo

llow

ing?

1.Sa

mpl

e se

lect

ion,

met

hod

desc

ript

ion,

val

idat

ion

ofm

etho

dolo

gy a

nd r

esul

ts,

acce

ptan

ce/r

ejec

tion

crite

ria,

and

use

of te

st r

esul

ts

6489

.99

75.0

196

.42

910

0.00

0.00

0.00

3382

.99

65.9

792

.47

210

0.00

100.

0010

0.00

2.M

etho

ds fo

r de

term

inin

gin

gred

ient

iden

tity

and

for

dete

ctin

g ad

ulte

ratio

n

5480

.44

66.5

489

.48

778

.77

45.1

394

.36

2971

.86

53.7

984

.85

210

0.00

100.

0010

0.00

3.Te

sts

to a

sses

s th

e st

abili

tych

arac

teri

stic

s of

pro

duct

s in

dete

rmin

ing

appr

opri

ate

stor

age

cond

ition

s an

d ex

pira

tion

datin

g(in

clud

e te

stin

g co

nduc

ted

atco

rpor

ate

head

quar

ters

)

4362

.29

47.1

475

.37

666

.32

31.5

589

.37

2054

.07

35.7

271

.38

210

0.00

100.

0010

0.00

4.Pr

oced

ures

for

hand

ling

and

filin

g te

st r

ecor

ds54

78.7

964

.60

88.3

26

67.3

733

.51

89.4

226

67.9

949

.93

81.9

00

0.00

0.00

0.00

No

answ

er1

0.64

0.09

4.45

00.

000.

000.

002

7.08

1.54

27.1

00

0.00

0.00

0.00

(con

tinue

d)


E-40

Ta

ble

E-6

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

6: Q

ua

lity

Co

ntr

ol a

nd

La

bo

rato

ry O

pe

rati

on

s (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

6.30

[If

6.26

is Y

es]

How

long

are

rec

ords

for

labo

rato

ryop

erat

ions

ret

aine

d?

1.__

_ ye

ar(s

) afte

r ex

pira

tion

date

2943

.60

29.5

958

.72

110

.35

1.45

47.5

17

12.8

35.

8525

.85

159

.18

8.09

95.9

8

2.__

_ ye

ar(s

) fro

m d

ate

ofm

anuf

actu

re28

38.1

725

.06

53.2

65

55.4

423

.78

83.2

223

64.1

647

.05

78.3

00

0.00

0.00

0.00

3.O

ther

1418

.23

9.36

32.4

93

34.2

111

.08

68.4

47

13.9

66.

5427

.34

140

.82

4.02

91.9

1

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

003

9.05

2.54

27.4

90

0.00

0.00

0.00

Mea

n ye

ars

afte

r ex

pira

tion

date

292.

32—

a—

13.

00—

—a

72.

01—

—a

11.

00—

—a

Mea

n ye

ars

from

dat

e of

man

ufac

ture

284.

743.

875.

615

5.00

3.57

6.43

235.

053.

676.

44—

f—

——

6.31

[If

6.26

is 1

or

2]D

oes

this

pla

nt v

erify

and

kee

pre

cord

s th

at la

bora

tory

equ

ipm

ent i

sca

libra

ted

corr

ectly

?

1.Y

es68

77.9

063

.53

87.7

09

75.4

044

.43

92.1

538

68.3

553

.75

80.0

52

100.

0010

0.00

100.

00

2.N

o11

19.6

610

.37

34.0

92

16.0

14.

0746

.11

1931

.65

19.9

546

.25

00.

000.

000.

00

Don

’t kn

ow1

0.52

0.07

3.65

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

00

No

answ

er2

1.93

0.42

8.33

18.

601.

1144

.15

00.

000.

000.

000

0.00

0.00

0.00

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.b E

stim

ated

con

fiden

ce in

terv

al fo

r lo

wer

bou

nd w

as le

ss th

an z

ero

so w

e tr

unca

ted

the

inte

rval

.c E

stim

ated

con

fiden

ce in

terv

al fo

r up

per

boun

d w

as g

reat

er th

an 1

00 s

o w

e tr

unca

ted

the

inte

rval

.d O

ne r

espo

nden

t in

the

amin

os/p

rote

ins/

anim

al e

xtra

cts

cate

gory

ent

ered

100

% fo

r qu

estio

n 6.

19 fo

r bo

th in

-pro

cess

mat

eria

ls a

nd fi

nish

ed p

rodu

cts.

The

mea

nsex

clud

ing

this

res

pons

e ar

e 2.

94 fo

r in

-pro

cess

mat

eria

ls a

nd 1

.70

for

finis

hed

prod

ucts

. (T

his

resp

onde

nt d

id n

ot a

nsw

er q

uest

ion

6.20

.)e C

onfid

ence

inte

rval

cou

ld n

ot b

e es

timat

ed b

ecau

se o

f mat

rix

conf

orm

abili

ty e

rror

.f C

ould

not

est

imat

e be

caus

e th

ere

wer

e no

res

pond

ents

for

that

que

stio

n.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


E-41

Ta

ble

E-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.1

Are

ther

e w

ritte

n pr

oced

ures

for

rece

ipt o

f die

tary

sup

plem

ent

ingr

edie

nts?

1.Y

es88

74.3

762

.79

83.3

08

49.2

326

.41

72.3

855

60.3

147

.41

71.9

21

17.5

82.

3765

.22

2.N

o (S

kip

to q

uest

ion

7.6)

1110

.40

4.85

20.9

14

23.6

18.

9649

.25

2016

.11

10.1

024

.70

229

.12

6.87

69.5

8

3.D

o no

t rec

eive

die

tary

supp

lem

ent i

ngre

dien

ts (S

kip

toqu

estio

n 7.

6)

1611

.78

6.21

21.1

93

18.5

05.

8745

.25

1719

.53

10.4

633

.51

335

.73

11.2

170

.99

No

answ

er3

3.46

0.84

13.0

81

8.66

1.25

41.5

85

4.06

1.64

9.68

117

.58

2.37

65.2

2

7.2

[If 7

.1 is

Yes

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

thes

e pr

oced

ures

are

bein

g fo

llow

ed?

1.Y

es75

83.5

670

.39

91.5

78

100.

0010

0.00

100.

0046

82.8

267

.98

91.6

31

100.

0010

0.00

100.

00

2.N

o (S

kip

to q

uest

ion

7.4)

1316

.44

8.43

29.6

10

0.00

0.00

0.00

813

.56

6.30

26.8

00

0.00

0.00

0.00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

3.62

0.50

21.7

80

0.00

0.00

0.00

7.3

[If 7

.2 is

Yes

]A

re r

ecor

ds m

ade

of a

ny c

orre

ctiv

eac

tions

take

n if

proc

edur

es a

re n

otfo

llow

ed?

1.Y

es, f

or s

ome

proc

edur

es34

43.7

930

.10

58.5

03

36.9

911

.60

72.4

223

41.3

925

.27

59.6

01

100.

0010

0.00

100.

00

2.Y

es, f

or a

ll pr

oced

ures

3143

.78

30.2

558

.30

450

.29

19.1

281

.24

1227

.56

13.3

148

.52

00.

000.

000.

00

3.N

o10

12.4

36.

2423

.22

112

.72

1.57

57.0

510

19.7

49.

6436

.20

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

11.3

11.

7048

.49

00.

000.

000.

00

(con

tinue

d)


E-42

Ta

ble

E-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.4*

[If

7.1

is Y

es]

Do

your

wri

tten

proc

edur

es fo

rre

ceip

t of d

ieta

ry s

uppl

emen

tin

gred

ient

s in

clud

e an

y of

the

follo

win

g?

1.W

ritte

n ac

cept

ance

cri

teri

a fo

rdi

etar

y su

pple

men

t ing

redi

ents

deve

lope

d by

a c

ompe

tent

indi

vidu

al

7073

.47

59.3

883

.99

787

.87

47.8

998

.28

3872

.61

57.4

283

.90

00.

000.

000.

00

2.C

ertif

icat

e of

Ana

lysi

ssp

ecifi

catio

ns84

97.5

592

.68

99.2

16

75.1

536

.88

93.9

942

80.1

466

.46

89.1

51

100.

0010

0.00

100.

00

3.R

epre

sent

ativ

e sa

mpl

e an

dau

then

ticat

ed p

lant

ref

eren

cehe

ld in

an

envi

ronm

enta

llyap

prop

riat

e re

posi

tory

for

each

rece

ivin

g an

d pr

oduc

tion

lot/b

atch

5560

.59

46.8

572

.85

336

.99

11.7

172

.20

2650

.76

34.2

367

.12

110

0.00

100.

0010

0.00

4.R

ecor

ds li

nkin

g th

e C

ertif

icat

e of

Ana

lysi

s to

the

iden

tity

of th

eun

proc

esse

d ra

w m

ater

ial a

nd to

the

finis

hed

prod

uct

7081

.39

69.1

189

.52

337

.57

11.9

972

.67

4076

.93

62.5

086

.97

110

0.00

100.

0010

0.00

5.R

ecor

ds to

trac

e an

d ve

rify

com

plia

nce

with

law

s on

har

vest

of w

ildcr

afte

d bo

tani

cals

57.

652.

5920

.52

00.

000.

000.

0014

19.1

511

.07

31.0

60

0.00

0.00

0.00

6.A

udit

reco

rds

conc

erni

ng th

ere

liabi

lity

of s

uppl

ier

Cer

tific

ate

of A

naly

sis

3037

.73

26.0

151

.09

450

.29

19.2

981

.07

1427

.53

14.4

546

.06

110

0.00

100.

0010

0.00

7.R

ecor

ds fo

r so

urce

of a

nim

alde

rive

d m

ater

ials

or

prod

ucts

1721

.31

12.2

434

.44

561

.84

26.9

787

.67

17.

741.

1138

.63

00.

000.

000.

00

(con

tinue

d)


E-43

Ta

ble

E-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.4

[Con

tinue

d]

8.R

ecor

ds fo

r fis

h an

d fis

hery

dem

onst

ratin

g th

at F

DA

fish

and

fishe

ry p

rodu

cts

HA

CC

Pre

gula

tions

are

follo

wed

10.

470.

073.

351

12.1

31.

7252

.11

12.

120.

2814

.14

00.

000.

000.

00

9.R

ecor

ds fo

r ra

w m

ater

ials

toas

sure

seg

rega

tion

of r

aw, i

n-pr

oces

s, a

nd fi

nish

ed p

rodu

ctan

d pr

otec

tion

agai

nst

adul

tera

tion

5053

.75

40.4

666

.52

336

.99

11.7

172

.20

2652

.41

35.8

568

.46

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

3.62

0.50

21.7

80

0.00

0.00

0.00

7.5

[If 7

.1 is

Yes

]H

ow lo

ng a

re r

ecor

ds o

n re

ceip

t of

diet

ary

supp

lem

ent i

ngre

dien

tsre

tain

ed?

1.__

___

year

(s) a

fter

expi

ratio

nda

te28

32.2

521

.26

45.6

42

24.2

75.

8262

.46

1521

.35

12.1

734

.72

110

0.00

100.

0010

0.00

2.__

___

year

(s) f

rom

dat

e of

man

ufac

ture

3334

.45

23.1

947

.78

563

.01

27.8

088

.29

2555

.94

40.3

370

.46

00.

000.

000.

00

3.O

ther

2529

.10

18.4

442

.70

112

.72

1.60

56.5

911

14.9

18.

0425

.99

00.

000.

000.

00

Don

’t kn

ow1

3.03

0.41

19.3

00

0.00

0.00

0.00

11.

390.

199.

610

0.00

0.00

0.00

No

answ

er1

1.17

0.16

8.04

00.

000.

000.

003

6.41

1.79

20.4

00

0.00

0.00

0.00

Mea

n ye

ars

afte

r ex

pira

tion

date

282.

36—

—a

22.

90—

—a

152.

13—

—a

11.

00—

—a

Mea

n ye

ars

from

dat

e of

man

ufac

ture

334.

32—

—a

55.

00—

—a

254.

98—

—a

—b

——

—

(con

tinue

d)


E-44

Ta

ble

E-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.6

Are

ther

e w

ritte

n pr

oced

ures

for

prod

uctio

n pr

oces

ses?

1.Y

es91

72.0

960

.29

81.4

710

61.1

836

.12

81.4

667

68.7

155

.43

79.4

93

41.2

412

.85

76.9

7

2.N

o (S

kip

to q

uest

ion

7.11

)7

4.65

1.58

12.9

04

23.9

09.

1849

.37

1211

.62

6.34

20.3

41

17.5

82.

3765

.22

3.N

o pr

oduc

tion

proc

esse

sco

nduc

ted

(Ski

p to

Sec

tion

8)15

19.1

010

.99

31.1

01

6.26

0.83

34.7

213

15.5

87.

2830

.27

223

.60

5.67

61.3

8

No

answ

er5

4.16

1.26

12.8

81

8.66

1.25

41.5

85

4.09

1.67

9.68

117

.58

2.37

65.2

2

7.7

[If 7

.6 is

Yes

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

thes

e pr

oced

ures

are

bein

g fo

llow

ed?

1.Y

es90

98.7

991

.74

99.8

310

100.

0010

0.00

100.

0057

87.4

877

.69

93.3

52

72.0

118

.44

96.7

0

2.N

o (S

kip

to q

uest

ion

7.9)

11.

210.

178.

260

0.00

0.00

0.00

810

.01

4.92

19.3

21

27.9

93.

3081

.56

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

002

2.50

0.60

9.82

00.

000.

000.

00

7.8

[If 7

.7 is

Yes

]A

re r

ecor

ds m

ade

of a

ny c

orre

ctiv

eac

tions

take

n if

proc

edur

es a

re n

otfo

llow

ed?

1.Y

es, f

or s

ome

proc

edur

es36

40.3

628

.39

53.6

13

28.8

39.

4761

.06

3158

.04

41.7

272

.78

00.

000.

000.

00

2.Y

es, f

or a

ll pr

oced

ures

4247

.92

35.6

260

.49

660

.94

30.0

485

.00

1626

.75

15.4

742

.15

210

0.00

100.

0010

0.00

3.N

o12

11.7

16.

2021

.03

110

.24

1.32

49.3

810

15.2

17.

7727

.65

00.

000.

000.

00

(con

tinue

d)


E-45

Ta

ble

E-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.9*

[If

7.6

is Y

es]

Do

your

wri

tten

proc

edur

es fo

rpr

oduc

tion

proc

esse

s in

clud

e an

y of

the

follo

win

g?

1.M

aste

r pr

oduc

tion

and

cont

rol

reco

rds

8390

.02

77.2

296

.01

769

.77

36.3

790

.31

5077

.65

65.2

786

.53

129

.40

3.52

82.6

3

2.B

atch

pro

duct

ion

and

cont

rol

reco

rds

8895

.66

82.5

699

.03

1010

0.00

100.

0010

0.00

6192

.43

83.7

996

.65

310

0.00

100.

0010

0.00

3.Eq

uipm

ent u

se a

nd c

lean

ing

reco

rds,

incl

udin

g da

tes

of u

sean

d pr

oduc

t and

lot n

umbe

r of

each

bat

ch p

roce

ssed

7781

.59

68.8

489

.90

989

.76

50.6

598

.68

4774

.98

63.1

783

.97

272

.01

18.4

496

.70

4.R

ecor

ds th

at d

emon

stra

te th

atau

tom

atic

equ

ipm

ent,

incl

udin

gm

echa

nica

l and

ele

ctro

nic

equi

pmen

t (co

mpu

ters

), us

ed in

the

man

ufac

turi

ng p

roce

ss is

desi

gned

, ins

talle

d, te

sted

,ca

libra

ted,

val

idat

ed,

mai

ntai

ned,

and

che

cked

toen

sure

that

they

are

cap

able

of

and

are

perf

orm

ing

the

inte

nded

func

tions

4649

.03

36.3

961

.79

550

.24

21.9

178

.42

2843

.67

29.4

459

.03

272

.01

18.4

496

.70

5.R

ecor

ds fo

r re

proc

essi

ng o

f apr

oduc

t66

71.6

558

.21

82.0

99

89.7

650

.65

98.6

836

54.3

139

.20

68.6

71

29.4

03.

5282

.63

6.R

ecor

ds to

ass

ure

that

cor

rect

labe

ls a

nd la

belin

g an

d sa

fepa

ckag

ing

mat

eria

ls a

re u

sed

8087

.61

76.4

293

.92

989

.76

50.6

598

.68

4567

.35

51.0

980

.29

272

.01

18.4

496

.70

7.R

ecor

ds to

per

mit

trac

king

the

hist

ory

of th

e m

anuf

actu

ring

proc

ess

8794

.98

82.8

798

.66

990

.71

55.6

698

.70

5786

.70

75.7

993

.14

272

.01

18.4

496

.70

(con

tinue

d)


E-46

Ta

ble

E-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.9

[Con

tinue

d]

8.R

eser

ve s

ampl

es o

f eac

h ba

tch

ofdi

etar

y su

pple

men

t pro

duct

are

reta

ined

and

sto

red

unde

rco

nditi

ons

cons

iste

nt w

ith th

epr

oduc

t lab

elin

g

8793

.98

81.7

898

.19

1010

0.00

100.

0010

0.00

5483

.17

72.0

190

.48

272

.01

18.4

496

.70

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

002

2.50

0.60

9.82

00.

000.

000.

00

7.10

[If

7.6

is Y

es]

How

long

are

rec

ords

on

prod

uctio

npr

oces

ses

reta

ined

?

1.__

___

year

(s) a

fter

expi

ratio

nda

te32

35.8

224

.38

49.1

22

19.5

34.

7054

.45

1620

.23

11.8

032

.47

142

.62

6.20

89.2

9

2.__

___

year

(s) f

rom

dat

e of

man

ufac

ture

3942

.66

30.4

255

.87

660

.00

28.7

884

.77

3863

.86

50.0

275

.72

129

.40

3.52

82.6

3

3.O

ther

1819

.99

11.4

632

.54

220

.47

4.94

56.0

58

9.68

4.78

18.6

21

27.9

93.

3081

.56

Don

’t kn

ow1

0.82

0.11

5.78

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

00

No

answ

er1

0.71

0.10

4.96

00.

000.

000.

005

6.23

2.54

14.4

90

0.00

0.00

0.00

Mea

n ye

ars

afte

r ex

pira

tion

date

322.

36—

—a

22.

90—

—a

163.

00—

—a

11.

00—

—a

Mea

n ye

ars

from

dat

e of

man

ufac

ture

394.

42—

—a

65.

00—

—a

385.

40—

—a

16.

00—

—a

(con

tinue

d)


E-47

Ta

ble

E-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.11

[If

7.6

is N

OT

3]D

oes

this

pla

nt u

se p

rodu

ctio

n an

dpr

oces

s co

ntro

ls th

at id

entif

y th

epo

ints

, ste

ps, o

r st

ages

in th

em

anuf

actu

ring

pro

cess

to p

reve

ntad

ulte

ratio

n?

1.Y

es79

76.3

163

.91

85.4

210

65.2

739

.09

84.6

249

56.4

843

.00

69.0

73

61.8

819

.92

91.3

8

2.N

o (S

kip

to S

ectio

n 8)

1716

.12

8.66

28.0

33

18.8

16.

3644

.15

2225

.45

16.3

337

.39

00.

000.

000.

00

No

answ

er7

7.57

3.02

17.7

32

15.9

23.

9546

.57

1318

.07

8.57

34.1

72

38.1

28.

6280

.08

7.12

* [

If 7.

11 is

Yes

]D

oes

this

pla

nt’s

pro

duct

ion

and

proc

ess

cont

rols

hav

e sp

ecifi

catio

nsth

at m

ust b

e m

et fo

r id

entit

y, p

urity

,qu

ality

, str

engt

h, a

nd c

ompo

sitio

nof

com

pone

nts,

ingr

edie

nts,

or

diet

ary

supp

lem

ents

and

pac

king

and

labe

ling

mat

eria

ls?

1.Y

es, f

or c

ompo

nent

s53

66.9

652

.62

78.7

15

51.1

823

.27

78.3

728

59.5

843

.11

74.1

30

0.00

0.00

0.00

2.Y

es, f

or in

gred

ient

s67

85.9

975

.41

92.4

75

51.1

823

.27

78.3

740

83.6

070

.06

91.7

33

100.

0010

0.00

100.

00

3.Y

es, f

or d

ieta

ry s

uppl

emen

ts65

81.0

467

.34

89.8

67

69.7

736

.12

90.4

031

61.2

944

.46

75.7

91

37.1

84.

5787

.97

4.Y

es, f

or p

acki

ng a

nd la

belin

gm

ater

ials

4964

.01

49.9

076

.05

879

.53

43.6

295

.12

3674

.01

57.7

985

.55

125

.64

3.07

78.9

9

5.N

o, n

one

of th

e ab

ove

13.

010.

4218

.53

00.

000.

000.

004

7.59

2.63

19.9

80

0.00

0.00

0.00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

1.76

0.24

11.9

40

0.00

0.00

0.00

(con

tinue

d)


E-48

Ta

ble

E-7

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

7: P

rod

uc

tio

n a

nd

Pro

ce

ss C

on

tro

ls (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

7.13

* [

If 7.

11 is

Yes

]D

oes

this

pla

nt c

ondu

ct te

sts

tom

onito

r th

e pr

oduc

tion

and

in-

proc

ess

cont

rol p

oint

s, s

teps

, or

stag

es to

ens

ure

the

iden

tity,

pur

ity,

qual

ity, s

tren

gth,

and

com

posi

tion

of c

ompo

nent

s, in

gred

ient

s, o

rdi

etar

y su

pple

men

ts?

1.Y

es, f

or c

ompo

nent

s41

45.8

732

.55

59.8

05

51.1

823

.27

78.3

720

34.9

722

.30

50.1

91

25.6

43.

0778

.99

2.Y

es, f

or in

gred

ient

s50

61.2

247

.06

73.7

07

69.7

736

.12

90.4

033

59.6

341

.53

75.4

42

62.8

212

.03

95.4

3

3.Y

es, f

or d

ieta

ry s

uppl

emen

ts53

64.8

350

.35

77.0

16

60.4

729

.32

84.9

428

55.4

539

.00

70.7

92

62.8

212

.03

95.4

3

4.N

o, n

one

of th

e ab

ove

1420

.80

11.3

734

.97

19.

761.

3945

.36

713

.42

6.17

26.7

60

0.00

0.00

0.00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

1.76

0.24

11.9

40

0.00

0.00

0.00

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.b C

ould

not

est

imat

e be

caus

e th

ere

wer

e no

res

pond

ents

for

that

que

stio

n.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


E-49

Ta

ble

E-8

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

8: W

are

ho

usi

ng

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

8.0

Doe

s th

is p

lant

or

site

hav

ew

areh

ouse

s to

sto

re r

aw m

ater

ials

,in

-pro

cess

mat

eria

ls, o

r fin

ishe

dpr

oduc

ts?

1.Y

es11

697

.41

86.4

399

.55

1610

0.00

100.

0010

0.00

9295

.91

90.3

298

.33

688

.46

47.7

898

.47

2.N

o (S

kip

to S

ectio

n 9)

22.

590.

4513

.57

00.

000.

000.

005

4.09

1.67

9.68

111

.54

1.53

52.2

2

8.1*

Doe

s yo

ur w

areh

ouse

hav

ete

mpe

ratu

re o

r hu

mid

ity c

ontr

ols?

1.Te

mpe

ratu

re c

ontr

ols

8273

.34

62.1

582

.17

639

.40

18.8

064

.60

6168

.84

56.2

779

.14

353

.45

17.9

185

.80

2.H

umid

ity c

ontr

ols

2527

.33

17.8

139

.49

00.

000.

000.

0014

13.1

17.

3722

.26

00.

000.

000.

00

3.N

o te

mpe

ratu

re o

r hu

mid

ityco

ntro

ls34

26.6

617

.83

37.8

510

60.6

035

.40

81.2

031

31.1

620

.86

43.7

33

46.5

514

.20

82.0

9

8.2

Are

ther

e w

ritte

n pr

oced

ures

for

stor

age

proc

edur

es to

con

trol

agai

nst p

hysi

cal,

chem

ical

, and

mic

robi

al a

dulte

ratio

n as

wel

l as

dete

rior

atio

n of

the

prod

uct a

ndco

ntai

ner?

1.Y

es75

63.9

051

.97

74.3

27

42.4

021

.01

67.0

651

56.8

843

.57

69.2

62

33.5

87.

9274

.82

2.N

o (S

kip

to q

uest

ion

8.7)

4136

.10

25.6

848

.03

957

.60

32.9

478

.99

4042

.24

29.9

555

.58

466

.42

25.1

892

.08

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

0.88

0.12

6.11

00.

000.

000.

00

(con

tinue

d)


E-50

Ta

ble

E-8

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

8: W

are

ho

usi

ng

(c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

8.3

[If 8

.2 is

Yes

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

thes

e pr

oced

ures

are

bein

g fo

llow

ed?

1.Y

es65

87.9

374

.33

94.8

27

100.

0010

0.00

100.

0034

74.3

559

.84

84.9

42

100.

0010

0.00

100.

00

2.N

o (S

kip

to q

uest

ion

8.5)

1012

.07

5.18

25.6

70

0.00

0.00

0.00

1624

.51

14.2

438

.84

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

1.13

0.15

7.96

00.

000.

000.

00

8.4

[If 8

.3 is

Yes

]A

re r

ecor

ds m

ade

of a

ny c

orre

ctiv

eac

tions

take

n if

proc

edur

es a

re n

otfo

llow

ed?

1.Y

es, f

or s

ome

proc

edur

es24

32.9

320

.10

48.9

33

41.6

013

.44

76.5

717

48.8

427

.43

70.6

91

59.1

88.

0696

.00

2.Y

es, f

or a

ll pr

oced

ures

3658

.05

42.1

272

.46

458

.40

23.4

386

.56

1233

.54

15.8

357

.52

140

.82

4.00

91.9

4

3.N

o4

7.43

2.11

23.0

30

0.00

0.00

0.00

412

.24

3.92

32.2

70

0.00

0.00

0.00

No

answ

er1

1.59

0.22

10.7

90

0.00

0.00

0.00

15.

380.

7430

.34

00.

000.

000.

00

8.5*

[If

8.2

is Y

es]

Do

your

wri

tten

proc

edur

es fo

rw

areh

ousi

ng in

clud

e an

y of

the

follo

win

g?

1.Pr

oced

ures

and

rec

ords

for

forw

ard

and

back

war

d tr

acin

g of

prod

uct

6892

.18

79.5

897

.27

710

0.00

100.

0010

0.00

4794

.65

85.8

598

.10

210

0.00

100.

0010

0.00

2.Pr

oced

ures

and

rec

ords

for

salv

aged

pro

duct

s th

at in

clud

epr

oduc

t exa

min

atio

n an

dre

proc

essi

ng a

s ap

prop

riat

e

5566

.53

50.9

379

.20

573

.17

36.2

192

.91

3158

.11

39.4

274

.73

140

.82

4.03

91.8

9

No

answ

er3

2.03

0.62

6.49

00.

000.

000.

003

4.22

1.29

12.9

50

0.00

0.00

0.00

(con

tinue

d)


E-51

Ta

ble

E-8

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

8: W

are

ho

usi

ng

(c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

8.6

[If 8

.2 is

Yes

]H

ow lo

ng a

re r

ecor

ds o

nw

areh

ousi

ng r

etai

ned?

1.__

___

year

(s) a

fter

expi

ratio

nda

te25

30.9

519

.59

45.2

01

13.4

11.

8456

.13

1523

.13

13.0

737

.59

210

0.00

100.

0010

0.00

2.__

___

year

(s) f

rom

dat

e of

man

ufac

ture

2430

.63

18.8

045

.72

457

.05

21.7

086

.42

2662

.21

46.5

475

.68

00.

000.

000.

00

3.O

ther

2030

.47

18.6

345

.62

229

.54

7.21

69.3

56

8.84

3.86

18.9

70

0.00

0.00

0.00

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

1.61

0.22

11.0

10

0.00

0.00

0.00

No

answ

er6

7.94

3.66

16.3

70

0.00

0.00

0.00

34.

221.

2912

.95

00.

000.

000.

00

Mea

n ye

ars

afte

r ex

pira

tion

date

252.

03—

—a

15.

00—

—a

153.

15—

—a

21.

00—

—a

Mea

n ye

ars

from

dat

e of

man

ufac

ture

244.

00—

—a

45.

52—

—a

265.

24—

—a

—b

——

—

8.7

Are

ther

e w

ritte

n pr

oced

ures

on

prop

er p

reca

utio

ns to

red

uce

the

pote

ntia

l for

mix

-ups

or

adul

tera

tion

or c

onta

min

atio

n of

ingr

edie

nts,

raw

mat

eria

ls, o

r in

-pro

cess

form

ulat

ions

(e.g

., sa

fety

con

trol

s an

d op

erat

ing

prac

tices

or

sepa

ratio

n of

ingr

edie

nts)

?

1.Y

es82

63.5

151

.73

73.8

89

54.9

230

.73

76.9

854

59.5

946

.11

71.7

62

33.5

87.

9274

.82

2.N

o (S

kip

to S

ectio

n 9)

2827

.42

17.9

839

.43

636

.42

16.8

761

.78

3335

.95

24.2

149

.65

466

.42

25.1

892

.08

Not

app

licab

le2

2.66

0.46

13.9

01

8.66

1.25

41.5

92

1.79

0.43

7.09

00.

000.

000.

00

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

002

1.79

0.43

7.09

00.

000.

000.

00

No

answ

er4

6.41

2.19

17.2

90

0.00

0.00

0.00

10.

880.

126.

110

0.00

0.00

0.00

(con

tinue

d)


E-52

Ta

ble

E-8

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

8: W

are

ho

usi

ng

(c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

8.8

[If 8

.7 is

Yes

]D

oes

plan

t man

agem

ent v

erify

and

keep

rec

ords

that

thes

e pr

oced

ures

are

bein

g fo

llow

ed?

1.Y

es75

93.2

085

.60

96.9

38

89.1

251

.06

98.4

744

83.5

269

.69

91.7

92

100.

0010

0.00

100.

00

2.N

o (S

kip

to S

ectio

n 9)

76.

803.

0714

.40

110

.88

1.53

48.9

49

14.9

47.

1128

.72

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

1.54

0.21

10.5

20

0.00

0.00

0.00

8.9

[If 8

.8 is

Yes

]A

re r

ecor

ds m

ade

of a

ny c

orre

ctiv

eac

tions

take

n if

proc

edur

es a

re n

otfo

llow

ed?

1.Y

es, f

or s

ome

proc

edur

es31

42.5

428

.84

57.4

94

48.8

218

.87

79.6

524

44.2

927

.08

63.0

01

59.1

88.

1095

.97

2.Y

es, f

or a

ll pr

oced

ures

3849

.14

35.0

463

.39

338

.38

12.4

773

.15

1229

.03

14.2

250

.25

140

.82

4.03

91.9

0

3.N

o6

8.31

3.20

19.9

01

12.7

91.

6256

.68

714

.84

6.34

30.9

90

0.00

0.00

0.00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

11.8

31.

7849

.83

00.

000.

000.

00

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

ther

e w

as o

nly

one

obse

rvat

ion

(res

pond

ent)

in a

str

atum

for

that

que

stio

n.b C

ould

not

est

imat

e be

caus

e th

ere

wer

e no

res

pond

ents

for

that

que

stio

n.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


E-53

Ta

ble

E-9

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

9: C

on

sum

er

Co

mp

lain

ts

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

9.1

Are

ther

e w

ritte

n pr

oced

ures

at t

hepl

ant o

r co

rpor

ate

leve

l for

han

dlin

gco

nsum

er c

ompl

aint

s?

1.Y

es86

74.5

563

.17

83.3

410

60.8

935

.42

81.5

551

58.1

346

.01

69.3

33

41.2

412

.85

76.9

7

2.N

o (S

kip

to q

uest

ion

9.6)

2923

.38

14.9

034

.72

639

.11

18.4

564

.58

4339

.50

28.6

551

.49

458

.76

23.0

387

.15

Not

app

licab

le (S

kip

toSe

ctio

n 10

)1

0.34

0.05

2.36

00.

000.

000.

001

0.88

0.12

6.12

00.

000.

000.

00

No

answ

er2

1.74

0.43

6.72

00.

000.

000.

002

1.50

0.36

6.06

00.

000.

000.

00

9.2

[If 9

.1 is

Yes

]D

oes

man

agem

ent v

erify

and

kee

pre

cord

s th

at th

ese

proc

edur

es a

rebe

ing

follo

wed

?

1.Y

es81

92.9

881

.55

97.5

59

90.1

953

.57

98.6

545

91.5

881

.41

96.4

33

100.

0010

0.00

100.

00

2.N

o (S

kip

to q

uest

ion

9.4)

57.

022.

4518

.45

19.

811.

3546

.43

68.

423.

5718

.59

00.

000.

000.

00

9.3

[If 9

.2 is

Yes

]A

re r

ecor

ds m

ade

of a

ny c

orre

ctiv

eac

tions

take

n if

proc

edur

es a

re n

otfo

llow

ed?

1.Y

es, f

or s

ome

proc

edur

es31

41.8

728

.80

56.1

85

54.3

924

.10

81.7

518

40.2

422

.04

61.6

00

0.00

0.00

0.00

2.Y

es, f

or a

ll pr

oced

ures

3845

.84

32.5

959

.71

445

.61

18.2

575

.90

2037

.00

20.8

456

.72

310

0.00

100.

0010

0.00

3.N

o12

12.2

96.

2922

.63

00.

000.

000.

006

12.1

54.

8627

.21

00.

000.

000.

00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

10.6

11.

5447

.45

00.

000.

000.

00

(con

tinue

d)


E-54

Ta

ble

E-9

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

9: C

on

sum

er

Co

mp

lain

ts (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

9.4*

[If

9.1

is Y

es]

Do

your

wri

tten

proc

edur

es fo

rha

ndlin

g co

nsum

er c

ompl

aint

sin

clud

e an

y of

the

follo

win

g?

1.Pr

oced

ures

for

hand

ling

all

wri

tten

and

oral

com

plai

nts

8397

.34

91.1

499

.24

879

.91

44.3

495

.20

4794

.15

84.7

597

.90

310

0.00

100.

0010

0.00

2.R

ecor

ds c

once

rnin

g th

e ha

ndlin

gof

com

plai

nts

incl

udin

g an

yin

vest

igat

ions

, inv

estig

atio

nfin

ding

s, a

nd fo

llow

-up

actio

nta

ken

7583

.17

69.0

391

.64

1010

0.00

100.

0010

0.00

4379

.72

56.0

892

.37

272

.01

18.4

096

.71

3.Pr

oced

ures

for

requ

irin

gre

port

ing

of s

erio

us a

dver

seev

ents

to F

DA

MED

WA

TCH

1516

.82

9.07

29.0

71

9.34

1.29

44.7

25

9.22

3.32

23.0

90

0.00

0.00

0.00

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

1.45

0.19

10.0

10

0.00

0.00

0.00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

001

1.45

0.19

10.0

10

0.00

0.00

0.00

9.5

[If 9

.1 is

Yes

]H

ow lo

ng a

re r

ecor

ds o

n co

nsum

erco

mpl

aint

s re

tain

ed a

t the

pla

nt o

rco

rpor

ate

head

quar

ters

?

1.__

___

year

(s) a

fter

expi

ratio

nda

te31

37.0

425

.06

50.8

72

19.6

24.

7054

.70

1429

.05

14.2

950

.15

142

.62

6.19

89.3

2

2.__

___

year

(s) f

rom

dat

e of

man

ufac

ture

2328

.48

17.6

542

.52

659

.81

28.8

884

.51

1835

.58

20.8

553

.65

129

.40

3.51

82.6

7

3.O

ther

3030

.66

20.1

443

.68

220

.57

5.02

55.9

414

28.0

813

.72

48.9

41

27.9

93.

2981

.60

Don

’t kn

ow1

3.02

0.41

19.2

10

0.00

0.00

0.00

22.

890.

7011

.18

00.

000.

000.

00

No

answ

er1

0.80

0.11

5.61

00.

000.

000.

003

4.40

1.35

13.4

40

0.00

0.00

0.00

Mea

n ye

ars

afte

r ex

pira

tion

date

311.

951.

382.

522

1.95

0.53

3.38

143.

041.

634.

451

1.00

1.00

1.00

Mea

n ye

ars

from

dat

e of

man

ufac

ture

234.

513.

895.

146

4.51

3.09

5.92

183.

973.

244.

691

6.00

6.00

6.00

(con

tinue

d)


E-55

Ta

ble

E-9

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

9: C

on

sum

er

Co

mp

lain

ts (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

9.6*

Wha

t are

you

r pr

oced

ures

for

hand

ling

adve

rse

even

ts a

ssoc

iate

dw

ith c

onsu

mer

com

plai

nts?

1.In

cide

nt is

rep

orte

d to

FD

A22

20.6

012

.49

32.0

43

18.5

05.

8745

.25

1216

.23

7.61

31.3

10

0.00

0.00

0.00

2.Pr

oduc

t is

test

ed fo

r id

entit

y an

dco

mpo

sitio

n86

73.0

961

.39

82.2

711

69.2

743

.37

86.9

058

58.5

345

.34

70.5

92

23.6

75.

6861

.47

3.Pr

oduc

t is

refo

rmul

ated

3632

.09

22.6

043

.32

16.

260.

8334

.72

2122

.54

12.9

236

.32

00.

000.

000.

00

4.Pr

oduc

t is

reca

lled

6859

.29

47.5

970

.03

1275

.24

48.7

590

.66

5863

.36

51.5

773

.74

229

.70

7.11

69.9

9

5.O

ther

2823

.72

15.1

435

.14

639

.11

18.4

464

.59

2220

.92

13.3

931

.17

458

.76

23.0

287

.16

Don

’t kn

ow1

0.34

0.05

2.37

00.

000.

000.

001

0.85

0.12

5.91

00.

000.

000.

00

No

answ

er2

1.47

0.36

5.86

16.

260.

8334

.72

98.

994.

4317

.41

00.

000.

000.

00

9.7

Doe

s th

is p

lant

hav

e a

reca

llpr

oced

ure

in p

lace

?

1.Y

es95

80.8

469

.74

88.5

315

93.7

465

.28

99.1

759

59.6

446

.42

71.6

03

41.2

412

.84

76.9

8

2.N

o18

16.4

79.

2727

.57

16.

260.

8334

.72

3133

.99

22.7

147

.43

458

.76

23.0

287

.16

No

answ

er4

2.69

0.96

7.31

00.

000.

000.

006

6.37

2.63

14.6

30

0.00

0.00

0.00

(con

tinue

d)


E-56

Ta

ble

E-9

. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

9: C

on

sum

er

Co

mp

lain

ts (

co

nti

nu

ed

)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

9.8*

Who

eva

luat

es r

epor

ts o

nco

nsum

er c

ompl

aint

s?

1.In

-hou

se m

edic

al p

erso

nnel

1411

.11

5.75

20.4

01

5.69

0.79

31.3

014

11.6

96.

8719

.20

229

.64

7.09

69.9

4

2.In

-hou

se s

cien

tific

per

sonn

el56

46.0

435

.04

57.4

46

36.4

216

.87

61.7

825

28.0

317

.95

40.9

52

29.7

07.

1169

.99

3.In

-hou

se q

ualit

y co

ntro

lpe

rson

nel

9678

.67

66.8

787

.07

1273

.13

46.0

589

.67

6565

.39

51.9

276

.77

341

.76

13.1

477

.26

4.In

-hou

se r

egul

ator

y af

fair

spe

rson

nel

4133

.45

23.5

745

.02

636

.71

17.0

062

.16

1716

.06

9.60

25.6

31

12.1

21.

6353

.50

5.O

utsi

de c

ontr

acto

r13

11.9

0—

a—

a0

0.00

—a

—a

119.

22—

a—

a2

23.6

0—

a—

a

6.O

ther

2218

.46

10.9

329

.47

426

.58

10.2

653

.41

2123

.21

13.5

036

.93

458

.76

23.0

287

.16

Don

’t kn

ow1

2.26

0.31

14.7

50

0.00

0.00

0.00

00.

000.

000.

000

0.00

0.00

0.00

No

answ

er0

0.00

0.00

0.00

00.

000.

000.

004

4.60

1.50

13.1

90

0.00

0.00

0.00

a Con

fiden

ce in

terv

al c

ould

not

be

estim

ated

bec

ause

of m

atri

x co

nfor

mab

ility

err

or.

*Tot

al m

ay s

um to

gre

ater

than

100

% b

ecau

se r

espo

nden

ts c

ould

sel

ect m

ore

than

one

ans

wer

.


E-57

Ta

ble

E-1

0. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

10

: Y

ou

r P

lan

t

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

10.1

Wha

t was

the

cale

ndar

yea

rdu

ring

whi

ch th

is p

lant

was

built

? (I

f mul

tiple

bui

ldin

gs, u

seda

te o

f old

est b

uild

ing.

)

Yea

r (m

ean

resp

onse

)10

519

7919

7619

8312

1972

1962

1982

7419

7919

7519

843

1981

1964

1998

10.2

Wha

t was

the

cale

ndar

yea

rdu

ring

whi

ch th

e di

etar

ysu

pple

men

t ope

ratio

ns b

egan

at

this

pla

nt?

(If m

ultip

lebu

ildin

gs, u

se d

ate

of e

arlie

stop

erat

ion.

)

Yea

r (m

ean

resp

onse

)10

719

8819

8619

9114

1985

1978

1992

8519

9119

8819

945

1995

1995

1996

10.3

Wha

t is

the

tota

l squ

are

foot

age

of th

is p

lant

?

Squa

re fe

et (m

ean

resp

onse

)11

093

,846

46,2

9714

1,39

514

66,0

2819

,580

112,

475

7727

,515

12,5

2942

,501

39,

667

0.00

a24

,074

10.4

Are

this

pla

nt’s

faci

litie

sco

nnec

ted

to a

city

wat

ersu

pply

?

1.Y

es (S

kip

to q

uest

ion

10.6

)10

284

.30

73.1

891

.35

1169

.27

43.6

386

.77

7078

.33

69.0

385

.43

341

.76

13.1

477

.26

2.N

o11

9.66

4.56

19.3

24

24.4

79.

2950

.63

2116

.51

10.5

424

.94

229

.12

6.87

69.5

8

Don

’t kn

ow1

2.25

0.31

14.7

10

0.00

0.00

0.00

10.

840.

125.

860

0.00

0.00

0.00

No

answ

er4

3.79

1.04

12.9

11

6.26

0.83

34.7

25

4.32

1.78

10.1

22

29.1

26.

8769

.58

(con

tinue

d)


E-58

Ta

ble

E-1

0. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

10

: Y

ou

r P

lan

t (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

10.5

[If 1

0.4

is N

o]Is

the

wat

er s

uppl

y at

this

pla

ntpo

tabl

e?

1.Y

es9

73.0

519

.08

96.8

94

100.

0010

0.00

100.

0015

72.1

549

.37

87.3

11

60.3

67.

8296

.47

2.N

o0

0.00

0.00

0.00

00.

000.

000.

003

13.9

34.

1737

.55

139

.64

3.53

92.1

8

Don

’t kn

ow0

0.00

0.00

0.00

00.

000.

000.

001

5.09

0.63

31.2

30

0.00

0.00

0.00

No

answ

er2

26.9

53.

1180

.92

00.

000.

000.

002

8.84

1.94

32.1

70

0.00

0.00

0.00

10.6

Doe

s yo

ur c

ompa

ny o

wn

plan

ts a

tot

her

loca

tions

?

1.Y

es38

30.7

021

.32

42.0

05

30.1

612

.83

55.8

814

13.8

67.

7023

.68

117

.58

2.37

65.2

2

2.N

o74

63.3

151

.76

73.5

210

63.5

838

.47

82.9

877

79.6

568

.83

87.4

06

82.4

234

.78

97.6

3

No

answ

er6

5.99

2.15

15.5

91

6.26

0.83

34.7

26

6.50

2.69

14.8

80

0.00

0.00

0.00

10.7

How

man

y em

ploy

ees

are

curr

ently

empl

oyed

at t

his

plan

t?

1.Fu

ll-tim

e (m

ean

resp

onse

)11

213

6.94

68.2

120

5.67

1465

.14

26.6

710

3.60

8832

.87

13.0

052

.75

410

.44

0.00

a27

.47

2.Pa

rt-t

ime

(mea

n re

spon

se)

5324

.46

0.00

a49

.64

316

.26

0.00

a41

.97

494.

332.

476.

194

1.93

0.14

3.71

10.8

How

man

y em

ploy

ees

empl

oyed

at

this

pla

nt a

re w

orki

ng in

qua

lity

cont

rol?

1.Fu

ll-tim

e (m

ean

resp

onse

)10

113

.28

6.48

20.0

814

5.82

2.84

8.80

722.

641.

983.

313

1.75

0.00

a4.

18

2.Pa

rt-t

ime

(mea

n re

spon

se)

433.

110.

935.

296

1.94

0.73

3.15

381.

531.

091.

974

0.70

0.00

a1.

46

(con

tinue

d)


E-59

Ta

ble

E-1

0. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

10

: Y

ou

r P

lan

t (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

10.9

For

the

mos

t rec

ent f

isca

l yea

r,pr

ovid

e th

e nu

mbe

r of

bat

ches

of

diet

ary

supp

lem

ent p

rodu

ct b

ypr

oduc

t for

m.

Mea

n re

spon

se in

bat

ches

a.Po

wde

r86

95.0

062

.44

127.

5610

101.

810.

00a

224.

8774

64.0

022

.21

105.

805

1.19

0.01

2.36

b.Li

quid

8648

.98

12.8

685

.11

1018

.01

0.00

a37

.23

7490

.64

52.7

212

8.57

55.

670.

00a

12.7

1

c.Pa

ste

861.

270.

00a

3.21

100.

090.

00a

0.26

7419

.96

0.00

a57

.59

50.

000.

000.

00

d.C

apsu

le86

126.

7778

.88

174.

6710

3.82

0.00

a10

.46

7425

.29

4.12

46.4

65

2.45

0.13

4.77

e.Ta

blet

or

capl

et86

166.

6010

1.32

231.

8710

0.89

0.00

a2.

6074

18.5

63.

1833

.94

50.

000.

000.

00

f.G

elca

p86

12.9

22.

5423

.30

100.

000.

000.

0074

0.83

0.00

a1.

875

0.00

0.00

0.00

g.O

ther

867.

360.

2914

.44

103.

410.

00a

8.46

7429

.42

9.55

49.2

95

0.98

0.00

a2.

78

h.O

ther

860.

000.

000.

0010

0.00

0.00

0.00

746.

130.

00a

15.2

75

0.00

0.00

0.00

Tota

l86

458.

9233

4.11

583.

7210

128.

0411

.19

244.

8874

254.

8316

8.54

341.

125

10.2

90.

8719

.70

(con

tinue

d)


E-60

Ta

ble

E-1

0. W

eig

hte

d R

esp

on

ses

for

Se

cti

on

10

: Y

ou

r P

lan

t (c

on

tin

ue

d)

Vit

amin

s an

d M

iner

als

(n =

118

)A

min

os/P

rote

ins/

Ani

mal

Extr

acts

(n

= 1

6)H

erba

ls a

nd B

otan

ical

s(n

= 9

7)O

ther

(n =

7)

95%

CI

95%

CI

95%

CI

95%

CI

n%

Low

Hig

hn

%Lo

wH

igh

n%

Low

Hig

hn

%Lo

wH

igh

10.1

0W

hat w

ere

the

gros

s sa

les

reve

nue

for

the

diet

ary

supp

lem

ent

oper

atio

ns o

nly

at th

is p

lant

for

the

mos

t rec

ent f

isca

l yea

r?

1.Le

ss th

an $

500,

000

2216

.19

9.41

26.4

55

30.4

512

.83

56.5

638

34.1

024

.25

45.5

34

58.7

623

.03

87.1

5

2.$5

00,0

00 to

just

und

er $

1m

illio

n8

4.73

1.69

12.5

93

18.2

15.

9543

.91

1522

.37

11.7

038

.53

00.

000.

000.

00

3.$1

to ju

st u

nder

$2.

5 m

illio

n13

19.9

311

.65

31.9

71

8.66

1.25

41.5

814

13.1

37.

4022

.24

112

.12

1.63

53.5

0

4.$2

.5 to

just

und

er $

5 m

illio

n8

7.49

3.15

16.7

52

11.9

52.

9038

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6711

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000.

000.

00

5.$5

to ju

st u

nder

$10

mill

ion

1915

.81

9.14

25.9

50

0.00

0.00

0.00

910

.14

3.92

23.7

80

0.00

0.00

0.00

6.$1

0 to

just

und

er $

20 m

illio

n14

7.79

4.45

13.2

91

6.26

0.83

34.7

24

4.92

1.64

13.8

40

0.00

0.00

0.00

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0 to

just

und

er $

50 m

illio

n11

11.0

45.

5220

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8334

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00.

000.

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00

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0 to

just

und

er $

100

mill

ion

42.

160.

756.

070

0.00

0.00

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00.

000.

000.

000

0.00

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00 to

just

und

er $

500

mill

ion

87.

513.

4015

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000.

000.

000

0.00

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0.00

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000.

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00

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mill

ion

or m

ore

00.

000.

000.

000

0.00

0.00

0.00

00.

000.

000.

000

0.00

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Don

’t kn

ow1

0.87

0.12

6.02

15.

690.

7931

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000

0.00

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0.00

No

answ

er10

6.47

3.40

11.9

72

12.5

23.

0739

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64.

902.

1410

.80

229

.12

6.87

69.5

8

a Est

imat

ed c

onfid

ence

inte

rval

for

low

er b

ound

was

less

than

zer

o so

we

trun

cate

d th

e in

terv

al.


E-61

Ta

ble

E-1

1. V

erb

ati

ms

for

Qu

est

ion

2.4

: W

hy

Do

es

this

Pla

nt

No

t F

ollo

w P

ub

lish

ed

GM

Ps?

Vit

amin

s an

d M

iner

als

It is

not

a m

anuf

actu

ring

faci

lity.

Jus

t a s

ales

and

mar

ketin

g si

te.

All

prod

ucts

dis

trib

uted

are

pro

duce

d by

oth

er c

ompa

nies

in fa

cilit

ies

who

lly w

ithin

thei

r co

ntro

l.

We

sub-

cont

ract

with

pac

kagi

ng c

ompa

nies

for

actu

al s

uppl

emen

t man

ufac

turi

ng.

(We

do n

ot h

ave

prod

uctio

n fa

cilit

y).

OEM

cus

tom

ers

do n

ot w

ant t

o pa

y fo

r ex

tens

ive

cost

s, i.

e., l

ab te

sts

of r

aw m

ater

ials

eve

n fin

ishe

d pr

oduc

ts.

Don

’t m

anuf

actu

re—

we

rely

on

man

ufac

ture

rs.

Not

a p

lant

.

We

do n

ot m

anuf

actu

re p

rodu

cts,

we

dist

ribu

te fi

nish

ed p

rodu

cts

only

.

Prop

osed

rul

e m

akin

g no

t fin

aliz

ed.

Ver

y ex

pens

ive—

we

are

smal

l.

We

don’

t man

ufac

ture

.

Do

not u

nder

stan

d ex

act m

eani

ng.

We

are

not m

anuf

actu

rer

in th

is p

lace

. O

nly

offic

e he

re.

I don

’t m

anuf

actu

re a

nyth

ing

or e

ncap

sula

te a

nyth

ing—

I’m n

ot a

pla

nt.

Dis

trib

utio

n on

ly.

Lim

ited

reso

urce

s.

We

are

stri

ctly

a d

istr

ibut

or a

nd r

ely

on o

ur v

endo

rs to

hav

e G

MPs

.

We

are

a bu

sine

ss o

ffice

.

Cur

rent

ope

ratio

ns h

ave

prov

en a

dequ

ate

and

safe

ove

r m

any

year

s. T

hous

ands

of s

atis

fied

cust

omer

s w

ith v

ery

few

com

plai

nts.

Not

eco

nom

ical

ly fe

asib

le

Too

cost

ly to

impl

emen

t.

We

hand

le 8

0-90

% r

aw m

ater

ials

of h

erbs

—on

ly a

bout

5 k

inds

of h

erbs

that

’s a

ll.

In d

evel

opm

ent a

t thi

s tim

e.

Die

tary

sup

plem

ent p

rodu

ct li

nes

are

not e

xten

sive

eno

ugh

to w

arra

nt fo

llow

ing

a pu

blis

hed

GM

P m

odel

.(c

ontin

ued)


E-62

Ta

ble

E-1

1. V

erb

ati

ms

for

Qu

est

ion

2.4

: W

hy

Do

es

this

Pla

nt

No

t F

ollo

w P

ub

lish

ed

GM

Ps?

(c

on

tin

ue

d)

Am

inos

/Pro

tein

s/A

nim

al E

xtra

cts

Cur

rent

pro

gram

str

onge

r th

an G

MPs

.

Not

a m

anuf

actu

rer—

only

res

ell b

ulk

ingr

edie

nts.

We

impo

rt p

rodu

cts

that

are

mad

e ov

erse

as a

nd d

epen

d on

our

sup

plie

rs to

follo

w G

MP

stan

dard

s.

Prod

ucts

pro

duce

d by

app

rove

d ve

ndor

.

We

are

not a

war

e of

pub

lishe

d G

MPs

for

impo

rter

s w

ho d

o no

t eve

r op

en d

rum

s. T

he p

rodu

cers

follo

w p

ublis

hed

GM

P.

We

do n

ot m

anuf

actu

re o

r bo

ttle

the

prod

uct—

Onl

y pr

ivat

e la

bel a

nd d

istr

ibut

e.

Her

bals

and

Bot

anic

als

Not

sur

e ho

w G

MPs

app

ly to

my

com

pany

. To

o bu

sy s

trug

glin

g to

sur

vive

to fi

nd o

ut.

Our

pla

nt is

sta

ffed

by o

nly

two

peop

le—

mys

elf a

nd m

y w

ife.

We

sim

ply

war

ehou

se a

nd r

e-sh

ip p

rodu

cts

whi

ch a

re p

acke

d by

pri

vate

com

pani

es.

Not

fam

iliar

.

We

man

ufac

ture

sin

gle

herb

tea

grow

n on

our

bio

logi

cal r

eser

ve.

As

a sm

all c

ompa

ny w

ith o

ne p

rodu

ct th

at w

e co

ntro

l fro

m s

eed

to m

atur

e pl

ant.

Not

fam

iliar

with

them

.

Not

req

uire

d.

Too

cost

ly a

nd u

nnec

essa

ry in

our

situ

atio

n.

Not

app

licab

le—

we

don’

t man

ufac

ture

pro

duct

s.

Do

not h

ave

enou

gh in

form

atio

n—w

ill s

et u

p in

200

0.

We

do n

ot m

anuf

actu

re.

We

are

just

a s

ales

and

mar

ketin

g of

fice.

I don

’t th

ink

they

are

ade

quat

e fo

r bo

tani

cal i

dent

ity.

It do

esn’

t see

m n

eces

sary

. W

e kn

ow th

e co

nten

ts/p

urity

of t

he g

oods

we

mak

e, a

nd h

ave

our

own

stan

dard

s fo

r pu

rity

and

san

itatio

n.

Publ

ishe

d pr

oced

ures

are

gen

eral

ly n

ot a

pplic

able

or

prac

tical

for

an h

erba

l man

ufac

turi

ng c

ompa

ny o

f our

siz

e.

We

do n

ot tr

ust t

he in

tent

of t

he in

spec

tors

. W

e ar

e af

raid

that

they

may

acq

uire

pro

prie

tary

man

ufac

turi

ng p

ract

ices

from

us.

I was

told

by

an F

DA

sta

ff m

embe

r th

at G

MPs

did

not

app

ly to

our

ope

ratio

n.

Onl

y be

caus

e I d

on’t

have

a c

opy

of p

ublis

hed

GM

Ps a

nd d

idn’

t kno

w w

here

to a

cces

s th

is in

form

atio

n.(c

ontin

ued)


E-63

Ta

ble

E-1

1. V

erb

ati

ms

for

Qu

est

ion

2.4

: W

hy

Do

es

this

Pla

nt

No

t F

ollo

w P

ub

lish

ed

GM

Ps?

(c

on

tin

ue

d)

Her

bals

and

Bot

anic

als

(con

tinu

ed)

Una

vaila

ble—

guid

elin

es n

ot e

stab

lishe

d.

GM

P no

t rea

dily

ava

ilabl

e an

d th

e ex

pens

e in

volv

ed.

We

are

not a

man

ufac

ture

r an

d th

is is

not

a p

lant

.

We

are

in th

e pr

oces

s of

impl

emen

ting

new

pro

cedu

res.

We

follo

w s

peci

fic p

roce

dure

s de

fined

by

clie

nts

and

we

are

usin

g ou

r ow

n G

MP

syst

em.

We

feel

we

have

GM

Ps in

pla

ce.

They

just

are

n’t t

he G

MPs

that

som

eone

els

e es

tabl

ishe

d, th

ey’r

e ar

e [s

ic]

own.

Wor

k in

pro

cess

. G

oal t

o be

by

6/20

00.

Non

e of

the

actu

al m

anuf

actu

ring

don

e at

this

loca

tion.

We

are

not m

anuf

actu

rer.

Our

man

ufac

ture

r fo

llow

s C

hina

’s a

nd/o

r A

ustr

alia

’s G

MPs

.

Raw

ingr

edie

nt s

uppl

ier.

We

are

a di

stri

buto

r.

We

are

a fa

rm a

nd p

rodu

ce b

ulk

herb

s m

ostly

.

Con

trac

t man

ufac

ture

rs—

mak

e an

d pa

ckag

e ou

r pr

oduc

ts—

we

repa

ckag

e in

to p

oint

of s

ale

disp

lays

onl

y.

Oth

er

Not

a m

anuf

actu

rer.

Man

ufac

turi

ng is

not

don

e at

this

pla

nt b

ut it

ems

in q

uest

ion

2.3

are

kept

on

file

by o

ur s

uppl

ier.

We

empl

oy th

e se

rvic

es o

f con

trac

t man

ufac

ture

rs fo

r al

l our

pro

duct

s. C

onse

quen

tly, t

he q

uest

ions

in s

ectio

ns 3

-7 a

re n

ot a

pplic

able

.

Loca

l san

itatio

n de

pt s

tand

ards

.

survey of manufacturing practices in the dietary ... 17, 2000 survey of manufacturing practices in...

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