DEPARTMENT OF HEALTH AND BUMAN SERVICES FOOD AND DRUG ADMJNISTRATION

DISTRICT ADDRESS AND P1iONE NUMBER

6000 Metro Drive, Suite 101 Bal timore , MD 2 121 5 (410) 779-5455 Fax: (41 0) 779- 5707

OATE(S) OF INSPECTION

7/23 / 2019-7/ 30/2019* FEINUMSER

3 013352224

NAME AND TTTI.E OF INDMOVAI. TO WHOM REPORT ISSUED

Ms . Reg ina N. Smerag linol o, Pharm D, Pharmacy Manager FIRM NAME

InfuScience, Inc . dba Bi o s c rip Infusion Services

STREET AOORESS

4151 Lafayette Center Dr ., Suite 600

CITY. ~1ATE, ZIP CODE. COUNffiY

Ch antil l y, VA 20151- 1220 TYPE ESTABUSHMENT INSPECTED

Producer of steri le drug products

This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. If you have an objection regarding an observation, or have implemented, or plan to implement, corrective action in response to an observation, you may discuss the objection or action with the FDA representative(s) during the inspection or submit this infonnation to FDA at the address above. If you have any questions, please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM I OBSERVED:

OBSERVATION 1 You produced beta.-lactam drugs without providing adequate segregation, cleaning of work surfaces and cleaning of utensils to prevent cross-contamination.

Specifically,

A. On July 25, 2019, a portion of"Meropenem 1 g/ 50 ml NS IVP Q8H" (Rx1§j (6) j) spouted out of the syringe onto the working surface of the ISO 5 classified area of laminar flow hood 1 during production. Upon completion of producing the product, cleaning was performed by wiping the exposed working surface of the laminar flow hood with a sterile wipe and steril (b) ( 4) !. Following, two additional beta-lactam products were produced with subsequent cleaning of the exposed working surface of the laminar flow hood with a sterile wipe and sterile(b) ( 4) ~-Immediately after, a non-beta-lactam product, "0.9% NaCL 500 ml IV daily via HP" (Rx b) (6) ) was produced without cleaning to prevent cross-contamination from a beta-lactam product. Rx ~b) (6) !was released and distributed.

B. On July 23, 2019, "Cefepime lgm/ 10ml NS Q24H IVP" (R£ (b) (6) D was produced while a non-beta-lactam product, unsealed vials of"Vancomycin 1000 mg/100 ml NS Ql2H EP" ( (b) (6) ), remained in the same ISO 5 classified area laminar flow hood, hool bTT~ Rx~b) (6) J was released and distributed.

OBSERVATION 2 The ISO 5 classified aseptic processing areas had visibly dirty equipment or surface.

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FO.Rl\l F.l>A 4&3 (09AIS) l'itEVIOL'S EDMON OBSOl.ElE INSPECTIONAL OBSERVATIONS PAGE 1 of 5 PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMlNISTRATION

OATE(S) OF l l'ISPECTION DISTRICT AODRESS /\ND PHONE NUMBER

600 0 Met ro Drive, Suit e 1 01 7/23 / 2019- 7 /30 / 2019* Baltimore , MD 21 215 FEJNUMBER

3013352 2 24 (4 10)77 9- 5455 Fax : ( 410)77 9- 5 7 0 7

NAME ANO TITI.E OF INDIVIDUAL TO WHOM REPORT ISSUED

Ms . Re gina N. Smerag l inol o, Pharrn D, Pharmacy Manag e r STREET ADDRESS FIRMNMIE

InfuScie nce , Inc . dba Bioscrip I nfusion 41 51 Lafayette Cente r Dr ., Suite 60 0 Se rvices CITY, STATE. ZIP OOOE. COUNTRY TYPE ESTABUSHMEN'f lNSPECTEO

Chantilly , VA 201 5 1- 1220 Producer of steri l e d rug products

Specifically, on July 23 - 26, 2019, the rear HEPA filter IS 4 oUo (4) I laminar air flow hoods~ were observed with white "staining." The l(b) (4) 1 supplies the ISO 5 classified production area with (b) (4) HEP A airflow. The «staining'' was not removed before or in between aseptic processing of all products produced in those hoods, such as "TPN 3-in- l 4000 mL, over 13 hours," (Rx b} (6) ]). Management stated that all total parenteral nutrition (TPN) products are produced in those~ hoods.

OBSERVATION 3 Personnel conducted aseptic manipulations and placed equipment/supplies in an area that blocked the movement of first pass air around an open unit, either before or after it was filled with sterile product.

Specifically,

A. On J}tl~ 25, 2019, during sterile production of."TPN 3-in-1 1055mL IV over 8 hrs" ~ 6) ), in hood ~a technician manipulated sterile connections between an IV lipid bag and the(o ( 4) I compounder such that IV bags hanging in the ISO 5 classified area blocked the exposed sterile connection from first pass air.

B. On JulY, 26( 2019, during sterile production of "TPN 3-in-1 4000 mL, over 13 hours," (Rx~b) (6) I), 1

in hoodr c• ~ 1er technician manipulated sterile connections betwe~~ (b) -( 4) I ~(o) (4) "IV bag and the[(o) (4) Jcompounder in front ofthe(o (4) J equipment such that the exposed sterile connection was blocked from first pass air in the ISO 5 classified area.

OBSERVATION 4 Personnel did not disinfect and change gloves frequently enough to prevent contamination.

Specifically,

A. On July 23, 2019, a technician reached with a gloved hand and forearm into a trash receptacle in the ISO 7 classified "IV Compounding Room" to push down trash and returned to aseptic processing of "TPN 3-in- I 1800 mL, over 12 hours, QD" (Rx ~b) (6) I) in the ISO 5 classified laminar flow hood without

EMPLOYEE($) SIGNATURE DATE ISSUED

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FORM FDA 483 (09/08) PRIMOUS EDlTJON OBSOLETE INSPECTIONAL OBSERVATIONS PAGE 2 of 5 PAGES

DEPARTMENT OF HEALTH AND BUMAN SERVICES FOOD AND DRUG ADMINISJRA TION

DISTRICT ADDRESS ANO PHONE 1''\JMBER OATE(S) OF INSPECTION

6000 Metro Drive, Suite 101 7/23/2019- 7/30/2019* Baltimore, MD 21215 FE1NUMBER

301 3352224 (410) 779- 5455 Fax : (410) 779- 5707

NAME AND TITLE OF INDIVIOUAl TO WHOM REPORT ISSUED

Ms. Regina N. Srneraglinolo, Pharrn D, Pharmacy Manager FIRM NAME STREET AOORESS

InfuScience, Inc . dba Bioscrip Infusion 4151 Lafayette Center Dr., Suite 600

Services CITY. STATE. ZIP COOE. COUNTRY TYPE ESTABLISHMENT INSPECTED

Chantilly, VA 20151-1220 Producer· of s t erile drug products

changing or sanitizing gloves and coveralls.

B. On July 23, 2019, technicians repeatedly reached back and forth between the ISO 7 classified "N Compounding Room" and the ISO 5 classified laminar flow hoods, such as to obtain materials from their respective stock carts and to use a(l5) (4) r, without changing or sanitizing gloves. Personnel touched surfaces located outside of the ISO 5 classified aseptic processing area with gloved hands and engaged in aseptic processing during production of "Cefazolin 2 g I 20ml in Sterile W~MffafYI-inge" (Rx Ko) (6) j) in b~i )bJr4

~TPN 3-in-1 17.50 niL IV 12 Hours" CRx K§HQI p in hoo<[_J.nd ''TPN 3-in-1 2100 mL" (Rx

415 (6) in hood(b)( lwith infrequent glove sanitization.

OBSERVATION 5 Materials or supplies were not disinfected prior to entering the aseptic processing areas.

Specifically, on July 23, 2019, technicians brought materials such as product vials, syringe pouches, and lV bags from the ISO 7 classified "IV Compounding Room" into the ISO 5 classified laminar flow hoods without disinfecting the outer surfaces. Transfers of materials without being dis~,e~ were observed during production

1of"Cefazolin 2 g/ 20ml in Sterilyb~ ter syringe" (Rx (15) (6 ) p in ho > 'fN 3-in-k,L7?0 mL IV 12 Hours" (R..x[(l5f(6) ) in hood and "TPN 3-in-1 2100 m.L" (Rx.[(15H6) ) in hood(b)

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, OBSERVATION 6 Disinfectant contact time (also known as "dwell time") and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection.

Specifically, S."l.:;;:. C'"l· 3:::, • \C.

~ , JZ: On July 25, 2019, during b) (4foleaning:(6) (4) 'K!?).(1,)

1 production operations, the use of ~ sinfectant Solution" sterile germicidal disinfectant in the ISO 5 classified laminar flow

hoods(b) (4) did not dwell to achieve your required contact time oi1<15) (4J l. Some areas of the hood had a drying time of less than five seconds.

~-~ ~ 0'1- - °!>� - \<\ ~ Jo. On July 23 - 26, 2019, upon usage of your disinfectant, sterile(b) (4) l_, on exposed working

surfaces of ISO 5 classified laminar flow hoods in between production of different products, your

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FORM FDA 483 (09/03) PREVIOUS EDmON OllSOUmi INSPE<.TIONAL OBSERVATIONS PAGE 3 or 5 PAGES

DEPARTMENT OF HEALm AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION

6000 Metro Drive, Suite 101 7/23/2019- 7/30/2019* Baltimore , MD 21215 FEIMJMBER

3013352224 (410)779-5455 Fax : (410)779-5707

NAME ANO TITLE OF lNOJ\IIDUAt TO WHOM REPORT ISSLEO

Ms. Regina N. Smeraglinolo, Pharm D, Pharmac y Manager FIRM NAME STREETAOORESS

InfuScience , Inc. dba Bioscrip Infus ion · 4151 Lafayette Center Dr., Suite 600 Services CITY. STATE. ZIP CODE. CO\JNTRY TYPE EST ABUSHMENT INSPECTED

Chantilly, VA 201 51-122 0 Producer of sterile drug products

required contact time for bactericidal activity of (b) ( 4) I was not achieved. Cleaning of some hoods had a sterile.(b) ( 4) I drying time of Jess than five seconds.

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<:. _.E'. On July 25, 2019, during(b) (4)] cleaning~b) (4) J production operations, your disinfectant~ steril~\ b) ( 4) i, was not used in ISO 5 classified laminar flow hoods ~b) ( 4) I FurthermK~f~, sterile b) (4) I disinfectarit was not used during[(b (4) J cleaning operations in ho ~ -previous production day, July 24, 2019. Sterile production operations were commenced in hoods(b) (4 ) .

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On July 24, 2019, during(b) (4 ) I cleaning operations, use of "[b) ( 4) Disinfectant Solution" sterile germicidal disinfectant on the ISO 7 classified "IV Compounding Room" floor did not dwell to achieve your required contact time oH b) ( 4) J. Some areas of the floor had a drying t ime of less than five seconds.

OBSERVATION 7

ISO 5 classified areas were. not certified under dynamic conditions.

Specifically, unidirectional airflow was not verified under dynamic operational conditions representative of your aseptic processing practices. Smoke studies performed in the~l 4

< ISO 5 classified laminar flow hoods did not demonstrate unidirectional airflow, for example, around IV bags hung in each hood and the presence of a repeater or~b) (4) Jpump.

OBSERVATION 8

The facility design was observed to allow the influx of poor quality air into a higher classified area.

EMP1.0YEE(SJ SIGNATURE DATE ISSUED

SEE REVERSE Sena G Dissmeyer , Investigator 7/30/2019 OF THIS PAGE ~?~

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FORM FDA 483 co,rosJ PREVIOUS l;J;)ID0NOBSO!Er£ INSPECTIONAL OBSERVATIONS PAGE 4 ol 5 PAGES

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DEPARTMENT OF HEALTH AND BUMAN SERVICES FOOD AND DRUG ADMINISTRATION

DA TE(S) OF INSPECTION OISTRtCTA01J1<cSSANOPHONENUMBER

7/23/2019-7/30/2019* 6000 Metro Drive, Suite 101 FEl,-.'UMBER

Baltimore, MD 2 1215 3013352224 (410)779- 5455 Fax : (410)779-5707

NAME ANO TI11..1c OF INOMDUAL TO WHOM AEPORT ISSUl:D

Ms. Regina N. Smeraglinolo, Pharm D, Pharmacy Manager STREET ADDRESS FIRM NAME

InfuScience, Inc . dba Bioscrip Infusion 4151 Lafayette Center Dr. , Suite 600

Services cooe. TYPE ESTABLISHMENT INSPECTED CITY, STATE. ZIP COUNTRY

Chantil ly VA 20151-1220 Producer of sterile drug products ,

Specifically, there are:f5f( 4) I locateq{£) ( 4) • the unclassified b ~ general pharmacy area and. the ISO 7 classified "IV Compounding Room." All production materials are exchanged (6) (4) (o) (4i

r permitting unclassified air to enter the ISO 7 classified area.

*DATES OF INSPECTION 7/23/2019(Tue), 7/24/2019(Wed), 7/25/2019(Thu), 7/26/2019(Fri), 7/30/2019(Tue)

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EMPLOYEE(S) SIGNATURE

Sena G Dissmeyer , Investigator DATE ISSUED

7/30/2019

FORM 'FDA 483 (O,/US) p)<£\qous EDITION 08SOL£TE INSPECTIONAL OBSERVATIONS PAGE 5 of 5 PAGES