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
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
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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.
2-1
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.
Section 2 — Sample Design
2-5
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
Initial Sample Size 27 20 6 34 87
Expected Number of Respondents 11 8 3 14 36
3. Herbals and Botanicals
Initial Sample Size 187 58 5 164 414
Expected Number of Respondents 76 24 3 67 170
4. Other
Initial Sample Size 64 61 25 24 174
Expected Number of Respondents 26 25 14 10 75
Total
Initial Sample Size 346 244 95 256 941
Expected Number of Respondents 141 100 54 105 400
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
Survey of Manufacturing Practices in the Dietary Supplement Industry
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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.
Section 2 — Sample Design
2-7
Table 2-3. Final Sample Sizes, by Sampling Strata
Size
Product Type Very Small Small Large Unknown Total
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
3-3
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
Product Type Very Small Small Large Unknown Total
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:
Section 3 — Survey Design and Administration
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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
Eligibility Rate (%) 93.18 94.87 88.13 88.89 90.32
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
Eligibility Rate (%) 63.29 65.16 42.11 38.79 54.55
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
Eligibility Rate (%) 93.01 93.23 84.85 82.61 90.32
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).
Section 3 — Survey Design and Administration
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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
Section 3 — Survey Design and Administration
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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.
4-1
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.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
Survey of Manufacturing Practices in the Dietary Supplement Industry
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.
Section 4 — Survey Results
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
)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
Type
of o
pera
tions
a
Man
ufac
ture
r62
53.4
939
.87
66.6
275
68.5
156
.62
78.3
99
62.5
934
.80
83.9
814
661
.68
53.0
069
.67
Rep
acka
ger/
rela
bele
r/en
caps
ulat
or23
26.6
415
.96
40.9
941
41.5
130
.25
53.7
43
23.5
07.
3554
.33
6734
.11
26.2
742
.93
Ingr
edie
nt o
r in
put
supp
lier
3021
.92
13.2
833
.98
4538
.63
27.7
550
.79
430
.48
11.8
158
.95
7930
.94
23.5
439
.48
Dis
trib
utor
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
Impo
rter
2823
.47
14.0
636
.50
4035
.00
24.4
247
.31
537
.66
16.1
865
.40
7330
.13
22.7
238
.75
Expo
rter
3129
.14
18.2
343
.13
4337
.47
26.6
949
.66
642
.83
20.0
269
.17
8034
.13
26.4
242
.79
Oth
er7
3.64
1.73
7.51
34.
581.
1516
.52
00.
000.
000.
0010
3.93
1.62
9.21
Prim
ary
line
of b
usin
essb
Vita
min
s an
d m
iner
als
1524
.13
13.4
939
.36
3642
.35
31.3
554
.16
968
.59
40.8
887
.34
6035
.81
28.1
944
.22
Her
bals
and
bot
anic
als,
not i
nclu
ding
ext
ract
s32
25.9
816
.02
39.2
224
17.8
110
.51
28.5
62
17.6
84.
3150
.61
5821
.35
15.2
129
.12
Her
bals
and
bot
anic
als
extr
acts
3926
.98
18.1
238
.17
2417
.27
10.4
627
.17
14.
490.
6126
.47
6420
.82
15.4
027
.52
Am
ino
acid
s1
0.57
0.08
4.01
20.
950.
233.
771
4.73
0.64
27.5
64
0.98
0.38
2.51
Prot
ein
prod
ucts
55.
961.
7318
.57
52.
330.
965.
521
4.51
0.61
26.5
811
4.02
1.73
9.06
Ani
mal
ext
ract
s0
0.00
0.00
0.00
00.
000.
000.
000
0.00
0.00
0.00
00.
000.
000.
00
Con
cent
rate
s,m
etab
olite
s, a
ndco
nstit
uent
s
31.
710.
515.
561
2.95
0.41
18.3
60
0.00
0.00
0.00
42.
260.
568.
65
Oth
er6
9.59
3.42
24.1
35
4.87
1.38
15.7
60
0.00
0.00
0.00
116.
663.
0513
.95
Mul
tiple
res
pons
es7
3.96
1.84
8.29
1611
.02
6.34
18.4
70
0.00
0.00
0.00
237.
374.
7111
.35
Non
-die
tary
supp
lem
ent p
rodu
ct1
0.57
0.08
4.01
10.
460.
063.
260
0.00
0.00
0.00
20.
480.
121.
94
(con
tinue
d)
Survey of Manufacturing Practices in the Dietary Supplement Industry
4-6
Ta
ble
4-2
. P
lan
t C
ha
rac
teri
stic
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
Prod
uce
othe
r fo
odpr
oduc
ts12
6.81
3.77
11.9
939
32.2
822
.26
44.2
51
7.62
1.03
39.4
752
19.9
214
.19
27.2
2
Prod
uce
drug
s
OTC
dru
gs9
6.12
3.01
12.0
317
11.4
26.
7518
.67
429
.40
11.2
657
.76
3010
.06
6.94
14.3
6
Rx
drug
s0
0.00
0.00
0.00
00.
000.
000.
000
0.00
0.00
0.00
00.
000.
000.
00
OTC
and
Rx
drug
s3
4.58
0.97
19.0
312
8.75
4.73
15.6
44
34.0
113
.51
62.9
719
8.26
4.84
13.7
5
Ow
n pl
ants
at o
ther
loca
tions
1521
.49
11.4
536
.68
3324
.54
16.4
734
.91
1075
.76
48.3
291
.26
5825
.91
19.1
234
.08
(con
tinue
d)
Section 4 — Survey Results
4-7
Ta
ble
4-2
. P
lan
t C
ha
rac
teri
stic
s (c
on
tin
ue
d)
Ver
y Sm
all (
n =
110
)Sm
all (
n =
114
)
95%
CI
95%
CI
nM
ean
Low
Hig
hn
Mea
nLo
wH
igh
Ave
rage
squ
are
foot
age
of fa
cilit
y91
24,6
7535
548
,994
102
71,3
5552
,980
89,7
30
Ave
rage
num
ber
of fu
ll-tim
e em
ploy
ees
102
7.63
6.06
9.20
103
95.5
173
.20
117.
81
Ave
rage
num
ber
of fu
ll-tim
e Q
C e
mpl
oyee
s79
3.01
0.18
5.85
997.
245.
319.
17
Ave
rage
num
ber
of b
atch
es p
er y
ear
8722
2.95
134.
5231
1.38
7655
4.07
407.
2570
0.89
Ave
rage
ann
ual g
ross
sal
es r
even
ue ($
)10
213
,803
,005
0.00
c34
,900
,000
101
27,9
54,9
8713
,000
,000
42,9
00,0
00
Larg
e (n
= 1
4)O
vera
ll (n
= 2
38)
95%
CI
95%
CI
nM
ean
Low
Hig
hn
Mea
nLo
wH
igh
Ave
rage
squ
are
foot
age
of fa
cilit
y11
595,
734
3,77
11,
187,
696
204
75,7
3342
,203
109,
263
Ave
rage
num
ber
of fu
ll-tim
e em
ploy
ees
131,
005.
2330
0.43
1,71
0.03
218
105.
4758
.66
152.
27
Ave
rage
num
ber
of fu
ll-tim
e Q
C e
mpl
oyee
s12
88.2
425
.65
150.
8319
010
.27
5.51
15.0
3
Ave
rage
num
ber
of b
atch
es p
er y
ear
1230
8.96
181.
5943
6.33
175
380.
8029
2.64
468.
95
Ave
rage
ann
ual g
ross
sal
es r
even
ue ($
)13
73,3
30,2
6314
,700
,000
132,
000,
000
216
23,9
71,3
0311
,600
,000
36,4
00,0
00
a Res
pond
ents
cou
ld s
elec
t mor
e th
an o
ne r
espo
nse.
b 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
.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
.
Survey of Manufacturing Practices in the Dietary Supplement Industry
4-8
Ta
ble
4-3
. 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
Follo
w a
pub
lishe
d G
MP
mod
el61
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
For
plan
ts fo
llow
ing
GM
Ps,
the
GM
P m
odel
use
da
FDA
Foo
d G
MPs
4168
.55
49.6
582
.81
5263
.99
51.6
674
.72
651
.86
24.9
277
.75
9964
.70
55.3
873
.03
Adv
ance
Not
ice
ofPr
opos
ed R
ulem
akin
g14
25.9
912
.46
46.4
223
33.0
921
.21
47.6
14
38.2
215
.16
68.1
941
30.9
921
.92
41.8
1
Nat
iona
l Nut
ritio
nal
Food
s A
ssoc
iatio
n(N
NFA
) GM
Ps
1327
.73
13.6
648
.21
2530
.16
19.3
343
.77
18.
571.
1443
.12
3927
.75
19.0
938
.47
FDA
Dru
g C
GM
Ps10
16.6
66.
7235
.71
2933
.57
22.1
847
.26
973
.84
41.2
291
.91
4830
.59
22.0
940
.67
U.S
. Pha
rmac
opei
aG
MPs
1016
.56
6.64
35.6
525
36.7
224
.92
50.3
77
56.7
128
.31
81.2
942
31.1
522
.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
Oth
er Q
A p
rogr
am11
20.1
8—
—b
933
.99
——
b0
0.00
——
b20
25.2
9—
—b
Cer
tific
ate
of A
naly
sis
2764
.55
——
b19
85.7
3—
—b
00.
00—
—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.
Section 4 — Survey Results
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
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.43
59.8
8
Leas
ed62
63.9
049
.73
75.9
943
40.2
029
.00
52.5
32
14.8
33.
6344
.59
107
48.8
140
.12
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
abou
t the
pla
nt
924
.33
9.49
49.6
338
60.3
545
.34
73.6
410
90.6
353
.87
98.7
757
52.3
540
.65
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
.51
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
.82
31.3
173
.33
4769
.33
52.8
881
.99
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)
Section 4 — Survey Results
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.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
Section 4 — Survey Results
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
Section 4 — Survey Results
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
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
Section 4 — Survey Results
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.
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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): ___________________________________
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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):_________________________________________
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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.
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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.
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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
2. No Skip to question 3.6.
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.
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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): ________________________________________________
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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.
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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.
4.7 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures
2. Yes, for all procedures
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.
2. No 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.
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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)
2. Facility owner (lessor) Skip to question 4.15.
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.
2. No 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)
2. Facility owner (lessor) Skip to question 4.19.
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.
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4.20 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.
4.21 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures
2. Yes, for all procedures
3. No
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5 Equipment
5.1 Are there written procedures on the cleaning, sanitizing,and maintaining of equipment and utensils?1. Yes
2. No Skip to question 5.4.
5.2 Does plant management verify and keep records that theseprocedures are being followed?1. Yes
2. No Skip to question 5.4.
5.3 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures
2. Yes, for all procedures
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.
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6 Quality Control andLaboratory Operations
6.1 Is there a unit or person responsible for quality control?1. Yes
2. No Skip to question 6.4.
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
2. No Skip to question 6.7.
A Certificate of Analysis isa statement from thesupplier about the identity,strength, quality, and purityof a dietary supplement rawmaterial, ingredient, orfinished product.
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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
3. No Skip to question 6.14.
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
4. Visual (macroscopic or microscopic)
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.
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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
2. No Skip to question 6.21.
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.
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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
4. Visual (macroscopic or microscopic)
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
4. Visual (macroscopic or microscopic)
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.
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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
2. No Skip to question 6.24.
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
2. No Skip to question 6.26.
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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
2. No Skip to question 6.31.
3. Do not have laboratory operations Skip to Section 7 on page 18.
6.27 Does plant management verify and keep records that theseprocedures are being followed?1. Yes
2. No Skip to question 6.29.
6.28 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures
2. Yes, for all procedures
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
2. ____ year(s) from date of manufacture
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.
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7 Production and ProcessControls
7.1 Are there written procedures for receipt of dietarysupplement ingredients?1. Yes
2. No Skip to question 7.6.
3. Do not receive dietary supplement ingredients Skip to question 7.6.
7.2 Does plant management verify and keep records that theseprocedures are being followed?1. Yes
2. No Skip to question 7.4.
7.3 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures
2. Yes, for all procedures
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.
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7.5 How long are records on receipt of dietary supplementingredients retained? (Circle one and enter number ofyears.)1. ____ year(s) after expiration date
2. ____ year(s) from date of manufacture
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
7.7 Does plant management verify and keep records that theseprocedures are being followed?1. Yes
2. No Skip to question 7.9.
7.8 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures
2. Yes, for all procedures
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.
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7.10 How long are records on production processes retained?(Circle one and enter number of years.)1. ____ year(s) after expiration date
2. ____ year(s) from date of manufacture
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
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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
2. No Skip to question 8.7.
8.3 Does plant management verify and keep records that theseprocedures are being followed?1. Yes
2. No Skip to question 8.5.
8.4 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures
2. Yes, for all procedures
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.
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8.6 How long are records on warehousing retained? (Circle oneand enter number of years.)1. ____ year(s) after expiration date
2. ____ year(s) from date of manufacture
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
2. No Skip to Section 9 on page 23.
8.8 Does plant management verify and keep records that theseprocedures are being followed?1. Yes
2. No Skip to Section 9 on page 23.
8.9 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures
2. Yes, for all procedures
3. No
Survey of Manufacturing Practices in the Dietary Supplement Industry
23
9 Consumer Complaints
9.1 Are there written procedures at the plant or corporate levelfor handling consumer complaints?1. Yes
2. No Skip to question 9.6.
9.2 Does management verify and keep records that theseprocedures are being followed?1. Yes
2. No Skip to question 9.4.
9.3 Are records made of any corrective actions taken ifprocedures are not followed?1. Yes, for some procedures
2. Yes, for all procedures
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
2. ____ year(s) from date of manufacture
3. Other (Specify):_________________________________________
Written procedures forconsumer complaintsspecify how all written andoral complaints regardingproducts are handled.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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):_________________________________________
Survey of Manufacturing Practices in the Dietary Supplement Industry
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 _____________________
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
6. $10 to just under $20 million
7. $20 to just under $50 million
8. $50 to just under $100 million
9. $100 to just under $500 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
Survey of Manufacturing Practices in the Dietary Supplement Industry
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.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
%Lo
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
940
.88
87.3
460
35.8
128
.19
44.2
2
2.H
erba
ls a
nd b
otan
ical
s, n
otin
clud
ing
extr
acts
3225
.98
16.0
239
.22
2417
.81
10.5
128
.56
217
.68
4.31
50.6
158
21.3
515
.21
29.1
2
3.H
erba
l and
bot
anic
al e
xtra
cts
3926
.98
18.1
238
.17
2417
.27
10.4
627
.17
14.
490.
6126
.47
6420
.82
15.4
027
.52
4.A
min
o ac
ids
10.
570.
084.
012
0.95
0.23
3.77
14.
730.
6427
.56
40.
980.
382.
51
5.Pr
otei
n pr
oduc
ts5
5.96
1.73
18.5
75
2.33
0.96
5.52
14.
510.
6126
.58
114.
021.
739.
06
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
31.
710.
515.
561
2.95
0.41
18.3
60
0.00
0.00
0.00
42.
260.
568.
65
8.O
ther
69.
593.
4224
.13
54.
871.
3815
.76
00.
000.
000.
0011
6.66
3.05
13.9
5
Res
pond
ent s
elec
ted
mul
tiple
resp
onse
s7
3.96
1.84
8.29
1611
.02
6.34
18.4
70
0.00
0.00
0.00
237.
374.
7111
.35
Non
-die
tary
sup
plem
ent p
rodu
ct1
0.57
0.08
4.01
10.
460.
063.
260
0.00
0.00
0.00
20.
480.
121.
94
No
answ
er1
0.54
0.07
3.82
00.
000.
000.
000
0.00
0.00
0.00
10.
240.
031.
67
(con
tinue
d)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
30.4
018
.75
45.2
734
34.4
323
.78
46.9
11
11.1
51.
5649
.74
5831
.46
23.7
440
.36
2.H
erba
ls a
nd b
otan
ical
s, n
otin
clud
ing
extr
acts
3238
.86
26.2
453
.17
6162
.42
51.0
172
.59
430
.48
11.8
158
.95
9750
.50
42.1
858
.80
3.H
erba
l and
bot
anic
al e
xtra
cts
2824
.48
14.9
137
.48
5449
.23
37.5
461
.01
322
.86
7.46
52.1
785
37.0
929
.19
45.7
6
4.A
min
o ac
ids
1316
.30
8.28
29.5
940
46.1
334
.85
57.8
32
15.2
43.
7745
.23
5531
.55
24.0
540
.16
5.Pr
otei
n pr
oduc
ts10
12.1
15.
2025
.69
3035
.59
24.9
447
.89
17.
621.
0339
.47
4123
.92
17.1
832
.28
6.A
nim
al e
xtra
cts
1010
.68
4.45
23.4
817
22.7
613
.65
35.4
50
0.00
0.00
0.00
2716
.31
10.3
324
.80
7.C
once
ntra
tes,
met
abol
ites,
and
cons
titue
nts
99.
113.
7420
.53
1925
.56
15.9
838
.27
17.
621.
0339
.47
2917
.47
11.4
925
.67
8.O
ther
31.
470.
464.
594
1.89
0.71
4.95
16.
540.
9034
.91
81.
950.
973.
90
Non
-die
tary
sup
plem
ent p
rodu
ct8
4.30
2.13
8.49
117.
954.
1314
.74
427
.37
10.1
855
.61
237.
384.
8111
.18
No
othe
r pr
oduc
t typ
es32
20.6
213
.11
30.8
813
10.0
54.
8519
.68
319
.73
6.12
48.0
748
15.1
510
.51
21.3
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
.19
27.2
2
2.N
o96
91.8
686
.32
95.2
874
66.5
854
.59
76.7
513
92.3
860
.53
98.9
718
378
.92
71.5
784
.77
Don
’t kn
ow1
0.54
0.07
3.82
00.
000.
000.
000
0.00
0.00
0.00
10.
240.
031.
67
No
answ
er1
0.79
0.11
5.53
11.
140.
167.
810
0.00
0.00
0.00
20.
930.
223.
86
(con
tinue
d)
Appendix D — Weighted Results by Establishment Size
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
?
1.Y
es, O
TC d
rugs
96.
123.
0112
.03
1711
.42
6.75
18.6
74
29.4
011
.26
57.7
630
10.0
66.
9414
.36
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
34.
580.
9719
.03
128.
754.
7315
.64
434
.01
13.5
162
.97
198.
264.
8413
.75
4.N
o95
85.1
073
.01
92.3
484
78.6
969
.95
85.4
26
36.5
916
.18
63.2
918
579
.26
72.9
084
.45
Don
’t kn
ow1
0.54
0.07
3.82
00.
000.
000.
000
0.00
0.00
0.00
10.
240.
031.
67
No
answ
er2
3.67
0.76
15.9
41
1.14
0.16
7.81
00.
000.
000.
003
2.18
0.61
7.47
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
.29
18.0
334
.24
211
.02
2.65
36.0
383
23.8
519
.26
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
.01
96.
843.
3313
.54
427
.35
10.1
755
.59
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
.57
32.4
75
34.9
714
.78
62.5
232
17.0
311
.33
24.8
0
4.N
atio
nal N
utri
tiona
l Foo
dsA
ssoc
iatio
n (N
NFA
)44
40.0
227
.69
53.7
665
60.8
849
.32
71.3
44
26.2
79.
7354
.09
113
50.0
041
.46
58.5
4
5.U
tah
Nat
ural
Pro
duct
s A
llian
ce(U
NPA
)1
0.52
0.07
3.66
53.
481.
348.
770
0.00
0.00
0.00
62.
010.
844.
72
6.O
ther
1313
.02
6.25
25.1
421
16.5
39.
7626
.63
212
.35
2.89
40.0
236
14.7
99.
7721
.76
Not
app
licab
le35
32.1
120
.80
45.9
826
19.7
812
.45
29.9
55
38.5
216
.69
66.2
166
26.1
219
.38
34.2
1
Don
’t kn
ow1
0.54
0.07
3.82
00.
000.
000.
000
0.00
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
.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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.
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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.
Appendix D — Weighted Results by Establishment Size
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix D — Weighted Results by Establishment Size
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.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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
.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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.
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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
.13
75.
742.
6711
.91
00.
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
7.$2
0 to
just
und
er $
50 m
illio
n11
11.0
45.
5220
.84
16.
260.
8334
.72
44.
701.
5713
.24
00.
000.
000.
00
8.$5
0 to
just
und
er $
100
mill
ion
42.
160.
756.
070
0.00
0.00
0.00
00.
000.
000.
000
0.00
0.00
0.00
9.$1
00 to
just
und
er $
500
mill
ion
87.
513.
4015
.80
00.
000.
000.
000
0.00
0.00
0.00
00.
000.
000.
00
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
ow1
0.87
0.12
6.02
15.
690.
7931
.29
00.
000.
000.
000
0.00
0.00
0.00
No
answ
er10
6.47
3.40
11.9
72
12.5
23.
0739
.25
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.
Appendix E — Weighted Results by Product Type
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)
Survey of Manufacturing Practices in the Dietary Supplement Industry
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)
Appendix E — Weighted Results by Product Type
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
.