SEE REVERSE OF THIS PAGE

02/20/2014

FORM I'DA 483 (09/08) PREVIOUS EDITION OBSOL&TF. INSP ECTI ONAL OBSER VATIONS PAGE I OF 7 PAG I::S

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINI~:.:.l'.:.::RA.:.!.-"':..:.TION'-'-t~=~-:===------------1

OISTRICT AOORESS AND PHONE NUMBER

One Montva l e Avenue Stoneham, MA 02180 (78 1 ) 587-750 0 Fax: (781) 587-7556 Industry Information: www.fda.gov/oc/ i ndustry NAME ANDnnEOF lNDIVDVAL TOWf<OM R ISSUED

TO : Thomas w. Kelsey, Regiona l Director of Pharmacy FIRM NAME

Central Admix t ure Pharmacy Services, Inc.

• .• SJREl>o AOORESS

55 Sixth Rd

DATE(S) OF INSPECTION

02/03/2014 - 02/20/2014* FEINUMSER

3004407863

CITY, STAT€, ZIP CODE, COUN"mY

Wobu rn, MA 0 1801-1767 'rYPE 6STABLISI<MENf INSPECTED

Producer of Ste rile Drugs

This document lists observations made by the FDA representative(s) during the inspection ofyour facility. They are inspectional observations, and do not represent a final Agency determination regarding your compliance. . Ifyou 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 tb.is information to FDA at the address above. Ifyou have any questions, please contact FDA at the phone number and address above.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1

The operations relating to the processing and packing of penicillin are not perfom1ed in facilities sepa rate from those used for other drug products for human use.

Specifically, the following practices and conditions were observed which increase the risk of cross contamination of compounded sterile preparations made in your facility with P-Lactam drugs and coritamimition of cephalosporin drugs with penicillin: I. Your firm does not provide adequate separation of13-Lactam drugs from other drug products for human use. Penicillin G

Potassium and cephalosporin drugs; Cefazoline, Ceftazidime, and Ceftriaxone are compounded in Laminar Air Flow (LAF) Hood g ocated in Antibiotic Compounding Room It adjacent to LAF Hood ii!Rwhich is used to compound Cardiop legia Solution and Total Parenteral Nutritionals (TPN); LAF Hood IIwhich is used to compound Continuous Renal Replacement Therapy (CRRT) solutions; and LAF Hood ii!Ralso used to compound CRRT solutio ns. Compounding operations involving these products and equipment may be conducted simultaneously. For example: On 02/06/2014, two Pharmacy Technicians and one Pharmacist were observed simultaneously compounding Penicillin G Potassium, 2.5 MU, Lot# 24-439407 in LAF

I Hoo<IQR and CRRT- CITRATE Solution, Lot# 24-439574 in LAF ood

II!Rwithin Antibiotic Compounding Room · . · H

2. Your firm does not provide adequate separation of penicillin and cephalosporin drugs. Penicillin G Potassium and cephalosporin drugs; Cefazoline, Ceftazidi me, and Ceftriaxone are compounded in Laminar Air Flow (LAF) Hoodll located in Antibiotic Compounding Room I sometimes on the same day. For example:

a. On 12/24/20 13 the following compounding sequence was conducted in LAF Hood iH • At • Compounding Penicillin GK SMU/250 ml NS, CAPS Rx # 24-43 1746 • At Compounding Penicillin GK 2.5MU/250 ml NS, CAPS Rx # 24-431747 • At Compounding Cefazolin 750 mg/30 ml DSW, CAPS Rx # 24-43 I 738

b. On 02/0612014 the following compounding sequence was conducted in LAF Hood~~ • At Compounding Penicilli n GK SMU/250 ml NS, CAPS Rx # 24-439406 • At Compounding Penicillin GK 2.5MU/250 ml NS, CAPS.Rx # 24-439407 • • At Compounding Cefazolin 500 mg/50 ml DSW, S Rx # 24-4394

DATE ISSUED

DEPARTMENT OF HEALTH AND HUMAN SERVI CES FOOD AND DRUG ADMINISTRATION

DISTRICT AOORESSANO PHONE NUMBER

One Montvale Avenue Stoneham, MA 02180 (781) 587-7500 Fax: (781} 587 - 7556 I ndustry Information: www.fda.gov/oc/industry

NAME AND mLE OF INOI\IJOUAL TOWHCM flEPORT ISSUED

TO: Thomas w. Kelsey, Regional Director of Pharmacy

OATE(S) OF INSPECTION

02/03/2014 - 02/20/2014 * FEINUMBER

3004407863

FIRM NAME

Central Admixture Pharmacy Services, Inc.

STREET ~DDRESS

55 Sixth Rd

ctrv, STI\n:<'"".'-ZIP"'C""oo""e'.·COU"""N"'TR""Y:r---

Woburn, MA 01801- 1767

---·--------~~P~EE~ST~Ahl~I~SH~~~-N~T~! ~~E~cft~O~----------

Producer of Sterile Drugs

------------------~

SEE REVERSE OF THIS PAGE

FO.RM JmA 48J {09/08)

EMPtOYEE(S) S:GNATIJRE

Edmund F. Mrak Jr ., InvestigatorCamerson E. Moo re, Investigator

DATE ISSUED

02/20/2014

PilEVJOUS EDIT JON OBSOL.ETE INSPE CTIONAL OBSERVATlONS PA<il> 2 OF 1PAGES

3. Personnel, equipment, and component movement through your cleanroom facilities is not adequately designed, controlled, and operated to separate ~-Lactam drugs 1rom other drug products for human use. For example:

a. Your central Anteroom is accessed by personnel from TPN Compounding Room Antibiotic Compounding RoomI Gowning Room, and Product Entry Room during multiple product operations. Personnel were observed moving from compounding rooms to the Anteroom and returning during compounding operations. On 02/06/2014, a technician was observed compounding CRRT- CITRATE Solution in Antibiotic Compounding Room l while Penicillin G Potassium was compounded in an adjacent LAF hood then leaving the room and performing TPN compounding operations in TPN Compounding RoonR

b.

I

b. The pressure differential and­ from Antibiotic Compounding Room adequately controlled to continuously meet your firm's specification . On 02/06/2014, during compounding of Penicillin G Potassium, 2.5 MU, Lot# 24-439407 in LAF HoodIt_and CRRT- CITRATE Solution, Lot# 24-439574 in LAF Hoodiltvithin Antibiotic Co!'flpounding RoomI the differential pressure said to be measured from the compounding room to the anteroom, read on a magnehelic gauge, was observed at least five times to fall below the specification to a minimum of t (b)(4 )

- with recovery taking from 20 seconds to one minute.

c. The doors between the Anteroom; TPN Compounding Room IIR Antibiotic Compounding RoomI Gowning Room; and Product Entry Room are not designed for hands free opening and are not interlocked to prevent opening at the same time.

OBSERVATION 2

Samples taken of drug products for determination ofconformance to written specifications are not representative.

Specifically, your sterility testing program does not include samples representative ofeach compounded preparation and process on each operational day. During the period 12/02/2013 to 01/30/2014 your records of compounding activity in LAF Hood iR show that on at least eight days samples were not taken from the for each ISO 5 LAF Hood used for used for anticipatory compounded sterile preparations with beyond use date exceeding parameters stated in your procedure, TP-CAPS-4000037, Sterility Testing Using (b) (4) , Effective: 11/27/2013. For example the following compounded preparations were not sampled for sterility testing:

• Cardioplegia Solution Lot# 24-437716, Compounded on 01/27/2014 • Oxytocin Lot# 24-435788, Compounded on 01/15/2014 • Magnesium Sulfate Lot# 24-430520, Compounded on 12/18/2013•

• Norepinephrine Lot# 24-430704, Compounded on 12/09/2013

S EE REVERSE OF THIS' PAG E

FORM FPA ~83 (09ffl 8)

EMPLOYEE($) SIGNATURE

Edmund F. Mrak Jr ., InvestigatorCamerson E. Moo r e, Investigator

DATE ISSUED

PR.EVJOOS EDITfONOBSOl. E'I'f. lNSPECTIONAL OBSERVATIONS PAGE 3 ()J' 7 PAGES

DEPARTMENT OF HEALT H AND HUMAN S.ER VICES FOOD AND DRUG ADMINISTRATIQN

DISTRICT ADDRESS AND PHON E IJWMBER

One Montva le Avenue Stoneham, MA 02180 (781) 587-7500 Fax: (781) 587-7556 Industry Information : www.fda.gov/oc/industry

AME ~.NOnnE OF INOIVlOUAl TO WHOM REPOR ISSUED

TO : Thomas W. Ke l sey, Regional Director of Pharmacy

OATE(S) OF IN SPECTION

02/03/2014 - 02/20/2014*·----1FE! NUMBER

3004407863

FIRM NAME

Central Admixture Pharmacy Services, Inc. CITY, STATE, ZIP CO{)!;, COUNTRY

Woburn, MA 01801-1 767

STREET ADDRESS

55 Sixth Rd

TVP ESTABLISHMENTINSPECTE D

Producer of Sterile Drugs

OBSERVATION 3

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Specifically, your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing and support areas as follows:

l . Total Particulate Count and Active Air sampling is not perforn1ed each operational shift in critical zones including l SO 5 classified laminar air flow (LAF) hoods and TPN work zones and Surface Monitoring is not performed at the end of daily operations in critical zones. Compounded sterile preparations are aseptically manipulated in these areas as part of daily operations; however, environmental monitoring for total airborne particulates, surfaces, viable airborne particulates, and personnel is performed -

2. Personnel performing Total Airborne Particulate monitoring in the ISO 5 and ISO 7 classified spaces of TPN Compounding Room ~ on 02/05/2014 was observed holding the handheld ..particle counter collection tube in a horizontal to 10-l S degree downward ori~ntation during sampling. The mouth of the s&mple collection tube did not appear to be directed into the expected air stream during this observation.

3. Personnel monitoring is limited to the assessment compounding personnel's fingers ·and sleeves and other critical areas to include the forehead, chest, and shoulders are not monitored .

4.

of4. Your environmental monitoring program does not include sampling for bioburden on surfaces frequent ly contacted by

personnel performing aseptic operations. For example: a. The located in ISO 5 classified

TPN work zones. b. The handles of portable carts used to move compounding components and other supplies and the amino

acid storage shelf cover. 5. You do not perform environmental microbial monitoring of any floor surfaces in the cleanroom facilities and directly

adjacent areas as part of a comprehensive monitoring program to evaluate the bioburden in areas used to support and compound sterile preparations.

6. Your environmental monitoring procedures do not call tor the identification of any viable colony recovered by surface sampling in ISO 5 critical sites.

1. Your environmental monitoring procedures do not call for the identification of any viable colony recovered by active air sa mpling in ISO 5 critical sites.

8. Your firm does not perform growth promotion testing on each lot of ready-prepared medium used in testing for environmental bioburden in classified cleanroom areas. · ·

DEPARTMENT OF 'HEALTil AND HUMAN SERVICES FOOD AND DRUG ADM IN ISTRATION

DISTRICT AOORESS ANDPHONE NUMBEJ!

One Montvale Avenue Stoneham., MA 02180 (7 81) 5 87-7500 Fax: (781 ) 587-7556 Industry Informa t ion: www. f da.gov/oc/ i ndu.st r y

TO: Thomas W. Ke l sey, Regional Director of Pharmacy

DATEjS)OF INSPECTION

02/03/2014 - 02/20/2014* .~=--=-------1

FEINUMBER

3004407863

~IRMNAME

Central Admi xture Pharmacy Services, Inc.

CITY, STATE. ZIP COOE, COUNTRY

Woburn, MA 01801-1767

STREET ADDRESS

55 Sixth Rd

TYP£ STABU SHME'HT INSPECTED

Producer o f Steril e Drugs ~~~~~~----------------·~

SEE REVERSE OF THIS PAGE

FORM I•'DA 48J (09108)

EMPI.OYEEfS) SIGNI\TUR£ ()ATE ISSUED

02/20/201 4

Pit£V/()(IS EO!TION O BSOlGTe INSPECfiONAL OBSERVATJONS PAOli 4 OF 7 PAGES

OBSERVATION 4

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.

Specifically, the following conditions were observed which increase the risk of introduction of objectionable bioburden and other contaminants to compounded preparations during processing and elevated bioburden in the compounding environment: 1. The unclassified space surrounding the cleanroom unit is contiguous with the warehouse and shipping I receiving area

and is not adequately protected from the outdoor environment when the shipping I receiving overhead door is opened. Insect carcasses were observed in the unclassified space immediately -adjacent to the cleanroom exterior.

2. The exit pass through with from the ISO 7 classified TPN Compounding Room passes directly to the unclassified space for discharge of finished sterile preparations. Your air flow pattern analysis (smoke study), performed on 03/22/2013, fails to evaluate the air flow patterns in the area of this exit pass through when the (b)(4) is in place and in use.

3.

II

3. Your video of the air tlow pattern analysi.s (smok~ study), performed on 03/2~/2013, .in the TPN Compounding Room critical zone appears ro display an obj~ctionable air flow pa~ern over ISO 5 classified TPN Compounding Bench II.The indicator "smoke" was observed to be can·ied downward from the point of introduction then back upward inside the front of the partial enclosure before retuming down to discharge at the front of the enclosure. This air flow pattern may be expected to come in contact with compounding personnel arms before flowing upward and returning to the area where aseptic conn.ections are made. During the inspection Pharmacy Technicians were observed making aseptic connections ofdrug components and receiving bags with the - pump for production of sterile compounded preparations including TPN within the region ofthe recorded objectionable air tlow. The report ofthe air flow pattern analysis (smoke study), performed on 03/22/2013, titled "Smoke Study ofClass 5 Zone" was approved as "passed" with no deviations documented by your facilities management and final approval by your Quality Unit on 04/16/2013

4.

I

4. Water was observed seeping from under loose sheet flooring in the Utility Room at a seam directly in the walkway of personnel who access cleanroom cleaning and sanitization supplies stored in the room. Water was also observed on the Utility Room .floor in the area ofthe lift pump which collects drainage from the utility sink for discharge to the sanitary drain. The corridor outside the Utility Room passes the cleanroom personnel hand wash station and leads directly to the cleanroom Gowning Room and Product Entry Room. Cleanroom personnel wearing plant dedicated footwear and warehouse personnel, administrative personnel, and visitors wearing outdoor footwear were all observed to use this common corridor.

5. A floor drain located in the unclassified area outside the cleanroom facility adjacent to the Compounding Rooms, Employee Locker Room, Employee Bathrooms, Utility Room, and cleanroom personnel hand wash station was observed to have an open petforated cover. According to management the drain is unused and is not on any sanjtization program.

6. The employee locker room and changing area used to store plant uniforms and dedicated shoes was not adequately cleaned. A buildup of dust, hair, and other debris was observed on the floor and the tops of lockers were visibly dusty.

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DR~G ADMINISTRATION

OISTRICT A OORESS ANO PHONE NUMeER

One Mon tvale Ave nue Stoneha m, MA 02180 (781) 587-7500 Fax: ( 781 ) 587-7556 Indus try I n formation : www. f da. gov/oc/industry

OATE(S) OF INSPECI!ON

02/03/2014 - 02/2 0/2 0 1 4* FEII~UMBER

3004407863

NAME AND TiltE OF INOIVIOUAL TOWHOM REPORT ISSUED

TO: Thomas W. Ke lsey, Regional Di rect or ~Me

Central Admi x ture Pharmacy Services , Inc. CITY. STAlE. ZIP CODE. COUNTRY

Woburn , MA 01801 -1767

of Pharmacy STR!;ET ADDRESS

55 Si xth Rd

TYPE ESTABLISHMENT INSPECTED

Producer of Sterile Drugs

// //

SEE REVERSE OF THIS PAGE

I'ORM f.DA 48J (09/08)

EMPlOVEE(S)SIGN~nJRE

Edmund F. Mrak Jr., Inves:-1.gator earnerson E . Moore , Invest J..gator

OATE ISSUEO

02 / 20/2014

~c:/0// { . ~ ~ __:,_

a•R.EVJOUS EDITIONOBSOLETE INSPECTIONAL OBSERVATIONS PAOE 5 OF 71'AGES

OBSERVATION 5

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and followed.

Specifically, the following practices and conditions we re observed which could contribute objectionable bioburden and other contaminants to compounded preparations during processing and bioburden ofthe compounding environment: l. The following poor aseptic technique was observed: A Pharmacy Technician was observed compounding CRRT

CITRATE Solution in Antibiotic Compounding Roonjl LAF HoodI repeatedly lifiin~ bottles~ from a cart in the room to . shoulder (making shoulder contact) to.loosen .the bottle clos.ure be ore placing eac bottle mto the ISO 5 classified LAF hood. Addit ionally, the technician did not sanitize the exterior ofthe bottles immediately before placement in the ISO 5 classified critical zone.

­

2. Personnel were observed entering the ISO 8 Classified Product Entry Room directly from the unclassified spaces adjacent to the cleanrooms wearing street footwear. One - employee was observed entering the same a rea without donning a protective cover ove- . The personnel 1111d .equipment traffic pattem includes all common spaces traveled by cleanroom personnel wearing P,lant dedicated footwear a.tJd warehouse personnel, administrative personnel, and visitors wearing outdoor footwear and outer clothing.

3. Wheels of equipment and component carts brought into the "grey side" ofthe ISO 8 Classified Product Entry Room directly from the unclassified spaces adjacent to the cleanrooms are either not sanitized or particulate d irt is not removed before the application of sanitizing solutions.

OBSERVATION 6

Protective apparel is not worn as necessary to protect drug products fro m contamination.

Specifically, your f1rm failed to ensure that compounding personne.l wear -cloth ing appropriate to protect drug product from contamination. For example:

I. Personnel were observed working in ISO 7 classified cleanroom areas including TPN Compounding Room~ Antibiotic Compounding RoomI , and the central Anteroom areas having exposed skin from the bridge

II,oft.he nose tot e top of the

forehead . Personnel were observed reaching into the ISO 5 Classified TPN Work Zone w hile compounding TPN, breaking the plane ofthe ISO 5 enclosure with the exposed facial area.

DEPARTMENT OF HEALTH AND HUMAN SERVICES fOOD AND DRUG ADMINISTRATION

DISTRICTADCIIESS AND PHONE NUMBER

One Montvale Av enu e Stoneham, HA 02 180

'oA.TE($) or. INSPECTION

02 / 0 3 / 2 0 14 - 02/20/2014 * -----··---1FE!NVMUER

3004 4 07 8 63 (78 1) 5 8 7 - 7500 Fax: (78 1 ) 5 87 - 7556 I ndus t ry Informa t i on : www.fda.gov/oc/ .i..ndustry NAME AND llT\.E OF INDIVtOOAl TO WHOM REPORT ISSUED

TO : Thomas W. Kel sey, Regi onal Direct o r of Pharmacy FIRM NAME

Centra l Admi x t ure Pharma c y Se rvices, Inc.

STREEf ADDRESS

55 Si xth Rd

CI'TY. STATEc.7iztPO.c'l'.cJ<\C:OE. CiVOU;;';Nu,TR;;;Yr-----

Wo bu rn , MA 01 801.- 1767

------------j'-TYTV;;;P~E'E'STr.:II;;;BL'"'tsHU':Mii'EN;:;;T'"tN"'SP"-'E"'CTE""D.,.------

Producer of Ster ile Drug s

-------'----J

~

SEE REVERSE OF THIS PAGE

FO.RM I'DA 483 (09i08)

Edmund F. Mra k Jr. , I nve s t i g atorCamerson E . Moor e , I nve stiga t o r 02 / 2 0/ 2014

PREVIOUS £DITION OBSOLETE INSPECfiONAL OBSERVATIONS PAGE 6 Of 7l'A0£S

OBSERVATION 7

Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications designed to assure that components conform to appropriate standards of identity, strength, quality and purity.

Specifically, your firm uses a component of inappropriate quality, (b) (4) , to compound CRRT- CITRATE Solu tion, a human drug intended for infusion. According to the batch record for CRRT - CITRATE Solution, Lot # 24-439574-0-1, E xp: 03/08/2014, , made up ..U ml of the total IIIII ml formulation.

OBSERVATION 8

Each Jot of components was not appropriately identified as to its status in terms of being quarantined, approved or rejected .

Spec ifically, you do not adequately control and identify the status of raw material components and store these components according to thei r status as quarantined, approved, or rejected. For example:

I . Your procedure, SOP-CAPS-4000157, Material Receiving Handling and Storage, said to include requirements for Quality Cont rol (QC) disposition ofraw materi al components for compounding of sterile preparat ions, identifies raw material co mpon ents such as as requiring QC control but you do not provide adequate just ification for excluding raw material components such as (b)(4) an (b) (4) fro m any requirement to be controlled by QC prior to use in compounding drugs for human use.

2. Raw material components such as (b) (4) and (b) (4) observed st ored in the warehouse and said to be in ".released status" do not .have any indication of status and are not segregated from quarantined and rejected components. ·

3. (b)(4) observed in the quarantine area on 02/03/ 20 14 and sa id to be available for use was not released by QC as required by SOP-CAPS-4000157, Material Receiving Handling and Storage.

OBSERVATION 9

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed .

Specifically, your Investigation# 24-130424-0 I 0 regarding precipitation observed in TPN did not seek to identifY the precipitate as part of a thorough root cause analysis or health hazard evaluation. The complaint investigation concluded on ly that: " The cause of the TPN precipitation cannot be determined by this investigation."

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

~O~~~~R~~~TA~0~00n£~SS~A~ND"~~~~E~NU~Mmee~R.-----

One Montvale Avenue Stoneham, MA 02180

----------~~~~~~~~~~~~~~O~Al~E(~S)~O~FI~NS~~=cr~IOO~--------------

02/03/2014 - 02/20/201 4*

------~

FEI NUMBER

3004407863 (781 ) 587-7500 Fax: (781) 587-7556 Industry Information: www.fda.gov/oc/ i ndustry NA tE AND TITlE OF INOIVICUAL 10 WHOM REPORT ISSUED

TO: Thomas W. Kelsey, Regional Directo.r of Pharmacy FIRM NAME

Central Admix·ture Pharmacy Services, Inc. CITY, STATE, ZIP CODE, CO~

Woburn, MA 01801-1767

STREET ADDRESS

55 Sixth Rd

TYPE ESTAilliSKMENT INSPE

Producer of Sterile Drugs o··------- ·- - --·-----f

OBSERVATION 10

Written distribution procedures are not followed.

SOP-CAPS-4000188, Storage and Delivery of Compounded Sterile Preparations, requires g for shipping refrigerated preparations. Cardioplegia Solution, Lot# 24-439055, packaged

on 14, was observed to be packed in a format outside the validated conditions stated in procedure SOP-CAPS-4000188. The packaging format calls for in each standard insu lated corrugated box . ~the shipping boxes for Cardioplegia Solution, Lot # 24-439055 were observed to contain on!- each aJidllllllshipping box contained only - . · ·

DATES OF INSPECTION: •02/03/20 14(Mon), 02/04/20 14(Tue), 02/05/20 l4(Wed), 02/06/20 14(Thu),.02/07 /20 14(Fri), 02/20/20 l4(Thu)

SEE REVERSE OF THIS PAGE

I'ORM f'DA 483 (09108)

OAT£ I$SUE0 - ­

02/20/2014

PREVIOUS EOitiOI' OBSOLETE NSPECTIONAL OBSERVATIONS lNSPECTIONAL OBSERVATIONS PAGE 7 01' 7 PAGES

The observations of objectionable conditions and practices listed. on the front of this form are reported:

1. Pursuant to Section 704(b) of the Federal Food, Drug and Cosmetic Act, or

2. To assist firms inspected in complying with the Acts and regulations enforced by the Food and Drug Administration

Section 704(b) of the Federal Food, Drug, and Cosmetic Act (21 USC 374(b)) provides:

"Upon completion of any such inspection of a factory, warehouse, consulting laboratory, or other establishment, and prior to leaving the premises, the officer or employee making the inspection shall give to the owner, operator, or agent in charge a report in writing setting forth any conditions or practices observed by him which, in his judgement, indicate that any food, drug, device, or cosmetic in such establishment {1) consists in whole or in part of any filthy, putrid, or decomposed substance, or (2) has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Secretary."