Dallas , TX 75230-3856 Producer of Sterile Dru Productsfdagov-afda-orgs/... · Meti'lotrexate - PF...

- 12/2 9 /2015*

1000371043

President and

Dallas , TX 75230-3856 Producer of Sterile Dru Products

This documemlists 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. If you have an objection regarding an observation, or have implemented, or p lan 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 information to FDA at the address above. If you have any questions, please contact FDA at the phone number and add ress above.

DURING AN INSPECTION OF YOUR FI RM WE OBSERVED:

OBSERVATION 1

Each batch ofdrug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.

Specifically,

A. Lack ofsterility testing for sterile p~ produced from 6f10 15 to 9fl0 15. From 6/lf1015 to 9/ l3f1015 your firm produced and released approximately - ots of product containing Alprostadil USP ( Prostaglandin El) (PGE) (a non-sterile[IDJGI]to sterile product) without performing sterility test ing.

B. Sterile to s~roducts wenlmRIW and tested for ste rility using an In-bouse steri lity test method that has not been va lidated.

C. Lack of endotoxin testing for non-sterile to sterile products produced from 6/ l flO 15 to date.

D. Per your Logged Formula Worksheets non-sterile products are issued extended Beyond Use Dates (BUDs), these products lack steri lity testing and ver ification ofsterility.

a. MJi: the fo llowing products containing PGE (a non-steriltliJQII) were released between tEJJQI~...!__..:__ ith 90 day BUD according to the Logged Formu la Worksheets.

SEE REVERSE OF THIS PAGE

P od N Rou te of BUD BUD r uu ame Admin Info

PAP+PHEN+PGE 30/1/0.02 MGIML INJECfABLE

PGE (b )(4 )

PAP+PHEN+PGE+ATRO 20/3/0.04/0. 1 MGIML INJECfABLE

PAP+PHEN+PGE J<W t/0.01 5 MGIML INJECfABLE

PAP+PHEN+PGE 30/1/0.01 MGIML JNJECfABLE

Injection 9/1/2015 90 days

PAP+PHEN+PGE 30/0.2510.02 MGIML ln' · 9/ l/2015 90 da INJECfABLE ~eetiOfl )'S

Shelby N. Marler , Investigator Ademola 0 . Daramola , Investiga t or

Storage

Refrigerator & Protect from Light

Refngc:ralor & Prolcct from L1gbt

Noo-Slc:nle to Sterile:

Non-Sterile to Steri le

12/29/2015

PA.GE I OF II PAGES

DEPAR TMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG AOMINlSTRATION

Ol.lE(S) OF IHSI'ECTlON D4STRICT AOOflESS AND PI10tE NUMBER

12/08/201 5 - 12/29 /2015 *4 0 4 0 No rth Cent r al Exp r essway, Suite 300 FEINUMBERDa llas , TX 7520 4 100037104 3

Industry Information : www. fda .gov/oc/ind ustry (214) 253 - 5200 Fax: (214) 253- 5314

NAME AND TITl.E OF INOI\IIOUAL TO IMiOM REPORT ISSUEO

TO: Andre w J . Komuves , Pr esiden t and CEO FIRM NAME

Doughe r ty ' s Pharmacy

CITY, STA TE.ZS' C00E. COUNTRY

Dallas , TX 75230- 3856

STREET ADDRESS

595 9 Royal Ln Suite 515 TYPE ESTAl!liSMoEHT INSI'ECTEO

Pro d ucer o f Ster i l e Drug Pr oducts

LotNumbtr P roduct Name

PO =(b) (4)

PAP+POE 15/0.005 MGIML INJECTABLE

PAP+PHEN+PGE 30/0.5/0.01 MGIML INJECTABLE

PAP+PHEN+POE 30/1/0.02 MGIML INJECTABLE

PAP+PHE+PGE+ATRO 9/1/0.01/0.1 MGIML INJECT ABLE

PAP+PHEN+PGE 30/1/0.02 MG/ML INJECTABLE

PAP+PHEN+PGE 30/1/0.01 MG/ML INJECTABLE

PAP+PHEN+POE 30/1/ 0.04 MGIML INJECTABLE

POE 40 MCGIML VIAL

PAP+PHEN+POE 30/0.25/0.01 MGIML INJECTABLE

PAP+PHEN+ PGE 15/0. 125/0.005 MGIML INJECT ABLE

PAP+PHEN+PGE+ATRO 20/310.04/0.1 MGIML INJECTABLE

(b)(4)

PAP+PHEN+PGE 30/ 1/0.02 MGIML INJECTABLE

PAP+PHEN+PGE 30/1/0.0025 MGIML INJ ECTAB LE



Route of Admio

Injection

Injection

Injection

Injection

Injection

Inject ion

Injection

Inject ion

Injection

Injection

BUD

9/2/20 15

912/2015

9/312015

9n12o15

9ni20IS

9nnot5

9n/20t5

9ni2015

9/812015

9/912015

BUD l nfo

90 days

90 days

90 days

90 days

90 days

90 days

90 days

90 days

Storage






Refrigerator

Surting Material

Non-Sterile to Sterile




Non-sterile to Steril e



Non Sterile to Sterile






EMPLOYE£( $ ) SIGHAT\JRE OI.TEISSUEO

Shelb y N. Marler , Inves t igatorSEE REVERSE Ademola 0 . Daramola , Inv e stigator ~J) 12/29/2015OF THIS PAGE

FORM FOA W (0Ml8) INSP ECTlONAL OBSE RVATIONS PAGE 2 OF I I PAGES

OBSERVATION 2

Written records are not made of investigations into unexplained discrepancies.

Specifically,

conducted on rEJIQ ftested air samples (Arr

·the

follows:

out resu resu exceeded the action level concentration of

ile actionable microorganisms were detected in air sample iland •

24 CFU (Gram positive rods, micrococcus, S. coagulase, and other Fungi)

4 CFU (Alternaria, non-sporulating fungi) B. C. Sample

D. Sample

DEPARTMENT OF }IEALTH AND KUMAN SERVICES FOOD AND DRUG ADMINISTRATION

0ATE(S) Of' INSPECTIONR

12/08/2015 - 12/29/2015*4040 North Central Expressway, Suite 300 FEl-BERDallas . TX 75204 1000371043

Industry Information : www.fda.gov/oc/industry (214) 253-5200 Fax : (214) 253- 5314

NAME AND T LE Of' INDIVIDUALTO WHOM REPORT ISSUED

TO: Andrew J . Komuves , President and CEO FIRM NAME STREET ADDRESS

5959 Royal Ln Suite 515

Dougherty ' s Pharmacy

TYPE ESTABI.1&1MENT IHSPECTEDCITY, STATE. ZIP CODE.

Producer of Sterile Dru ProductsDallas , TX 75230- 3856

36 CFU (Bacillus, gram positive rods, Micrococcus, S. coagulase, and other Fungi)

4 CFU (Cladosporium fusarium)

Although the failure was recorded on the test report, however the final certification report showed the status of'PASS ' for all samples taken.

The finn did not conduct an investigation to determine the root cause ofthe failed certification and to assess the preventative and corrective action for the failure. Additionally, the firm continued to use the clean room to manufacture and distribute the following sterile drug products.

Date M1d e Lot Number Product BUD

Methotrexate - PF 09/03/2015(b) ( 4 );;(b ) ( 4 )I 09/14/2015Mitomycin - PF

Mitomycin - PF 09/18/201 sII I Mitomycin - PF 10/05/2015II I

I Methotrexate - PF 10/05/2015II Mitomycin- PF 10/2612015II I Mitomycin- PF 10/2912015II I

I Methotrexate- PF 5II Ganciclovir - PF 11/0912015II I Mitomycin- PF 1112412015II I

I Meti'lotrexate - PF 12102/2015II EMPLOYEE($) S4GNATUAE

Shelby N. Marler , Investigator ~ SEE REVERSE

Ademola 0 . Daramola , Investigator ~1)OF THIS PAGE

OATE IS$lJEl)

12/29/2015

JNSPECllONAL OBSERVATIONS PAG£ 3 Of II PAGES

- 12/29/2015*12/08/2015

100037104 3

Pre sid e n t a nd

Dallas TX 75230- 3856 Producer of Sterile Dru Products

OBSERVATION 3

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

Specifically,

A. Your finn fail ed to conduct environmental monitoring of air, personnel and surface during daily production periods, within the JSO 7 cleanroom and ISO 5 LFH used to prepare you r steri le drug products.

For example:

a. During the period covering June 2015 to December 20 15, no environmental m~air, personnel, or surface was performed by your firm. During this period, an average number o~terile drug product fonnulaHI . were manipulated, filled and distributed from your facility per day

b. There are SO 5~Laminar Air [OJDJitocate with~se ISO

B. On 1218fl0 15, we observed drug product manipulation activities in the lSO 5 LFH located in the ISO 7 Buffer Room during this time we did not observe any passive air monitoring in the ISO 5 LFH or any other environmental monitoring to ensure aseptic technique. Furthermore, there is a lack of personnel monitoring for daily aseptic operations.

OBSERVATION 4

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength , quality and purity at the time of use.

Specifically,

were ensure strength, quality, and purity. Furthermore, no stability testing or data has been perfonned.

For example: _~.-J...,.

A. is

SEE REVERSE 12/29/2015OF THIS PAGE

Bulk[tjJIIIklprostadil USP used to produce the following

a.

(b) ( 4)

(b) ( 4)

Shelby N. Marler, Investigator YV1 Ademola 0 . Daramola , Investigator~

PAGE 4 OF II PAGES

DEPARTMENT OF HEALTH AND RUMAN SERVICES FOOD AND DRUG ADMTNISTRATION

DIS TAOORESS NIO- NUMBER

40 4 0 North Central Expres sway, Suite 300 Da l las, TX 7520 4 (214) 253- 5200 Fax : (214) 253 5314 I ndustry Information : www. fda . gov/oc/industr

OA (S) OF IKSP€CTION

12/08/2015 - 12/29/2015 * FEI M8ER

1000371043

N.<.ME AND TlTl.E OF INCIVIDUALTO \M10M REPORT ISSUED

TO: And rew J . Komuves, Presid ent a nd CEO FIRM NAME

Dou gherty's Pharmacy S TREET AOORESS

595 9 Royal Ln Suite 515 TYPe ESTABUSHMENT INSPECTEC

Dal l as , TX 75230 3856 Pro duc er of Ste rile Drug Products

(b) (4) Expiration Date (b) (4) I. PGE

2.

3.

4. (b) ( 4) (b)(4)

Lot Number:

Date: ..U Lot Number:

n Date: ; Lot Number:

5. PAP+PGE 15/0.005 MGIML INJECTABLE; Production Date: 1011 912015; Lot Number: ~ 111 712016

(b) ( 4) b.

2.

3. Number: (b)(4)

Date: 18/0.5/0.006 MGIML INJECT; Production Date: 11 /0212015; Lot

Expiration Date: 1131 /2016

OBSERVATION 5

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and stre ngth of each active ingredient prior to release.

Specifica lly, A. Your firm fa iled to conduct potency testing ofyour sterile finished products at the time of release. From June 20 15

to December 8 2015 , your firm produced and distributed about 111 batches ofsteri1e drug products . Out ofthe 111 batches distrib uted. . % had extended Beyond Use Date (BUD) of90- 180 days. The drug products were not tested for potency to ascertain that the suitability throughout the BUD.

B. Your finn failed to conduct preservative content testing of your sterile fin ished products at the time of release . Your finn uses several differen t sterile form ulations which contained - md preservatives, or

(b) (4) •reservatives and were released for patients use without performing preservative content testing.

DATE ISSUED EMP\.OYEE(S) SIGNATURE

Shelby N . Ma r ler , Investigator ~ SEE REVERSE 12/29/2015Ademola 0 . Daramola , I nvestigator ~ OF THIS PAGE

PAGE 5 Of 11 PAGESINSPECTIONAL OBSERVATIONS FORJ\1 FDA 413 09

OEI'ARTMENT OF HEAL.TH AND RUrt1AN SERVICES FOOD AND DRUG ADM!NlSTRATION

4040 North Central Expressway, Suite 300 12/08/2015 - 12/29/2015*Dallas , TX 75204 fEJ NUMBER

(214 ) 253- 5200 Fax : (21 4) 253-5314 1000371043 Information : www. fda . gov/oc/industry

TO : Andrew J . Komuves , President and CEO

Dougherty ' s Pharmacy 5959 Royal Ln Suite 515 TYPE ESTAIIUIIHMENT INSPECTED

Dallas , TX 75230- 3856 Producer of Sterile Drug Products

OBSERVATION 6

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug product containers conform to appropriate standards of identity, strength, quali ty and purity.

Specifically,

Your finn's product inspection process is deficient in that you do not perform 100% visual checks, against a contrasting background of your sterile liquid fonnu lations prior to release. According to the "Compounding" Manager, abou- ofthe fmished products are visually inspected. Additionally, your fmn has nor established a written procedure for performing visual checks within products.

OBSERVATION 7

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written, and followed.

SpecificalJy, your cleanroom practices are deficient to prevent product contamination.

For example:

A. From 12/8/2015 to 12/11 /20 15, we observed an approximately two (2) feet by three (3) feet s ilver color metal cart used forth in the ISO 7 Buffer Room directly in front ofa return air vent located on the base

of the wall next to the rear ofthe ISO 5 Laminar Air Flow Hood ( LFH). We also observed a chair with -an approximate 3" diameter s ilver color metal base being placed directly in front ofthe return air vent located on the base of the wall in the ISO 7 Buffer Room next to the front of the ISO 5 LFH. This chair is on ly positioned in this

location during drug manipulation activities. The certification ofyour ISO 7 Buffer Room and ISO 5 LFH was not done during drug manipu lation activities. Furthermore, there is an approximately two (2) feet by four (4) feet silver

shelving unit with cleaning and gowning material stored in front ofthe return air vents in the ISO 7

Gowning/Preparation Room.

B. There is no evidence that smoke studies were conducted under dynamic conditions within ISO 5 areas used to sterilize by [IIQJmd filJ drug product unit containers.

C. On 12/8/2015, we observed your technicians manipulating multiple drug products (non-sterile to sterile and sterile to

sterile) using the same LFH at the same time. Per the certification of the LFH done o1i§lijM, the maximum

occupancy is - Furthermore, no precautions are taken to prevent potential c ross contamination caused by sharing a single ISO 5 LFH.

Lot N umber Produc:t !'1m~

I!MP\.OYE£(8) IIGHIITIJA£ DATE ISSUED

Shelby N. Marler, Investigatorl1~SEE REVERSE 12/29/2015Ademola 0 . Daramola , Investigator ~_t)OF THIS PAGE

FORM fDA oW (.,IM) INSPECTI ONAL. OBSERVATI ONS PAGE 60F II PAGES

DEPARTMENT OF HEALTH AND HUMAN SERVl CES FOOD AND DRUG ADMINlSTRATION

01 RICT ADDRESS NJO f'tiONE NUMBER

4040 North Central Expressway, Sui t e 300 Dallas , TX 75204 (21 4 ) 253-5200 Fax : (21 4 ) 253-5314 Indus try Information : www . fda . gov/oc/ i ndustry

TE(S) Of INSPECTION

12/08/2015 - 12/29/2015* FE! NUMBER

1000371043

TO: Andrew J . Komuves , President and CEO

Dougherty ' s Pharmacy STREET ADORESS


CITY, STATE, DP CODE, C0<JNTRY TYPE EST~ INSPECll!D

Dallas, TX 75230- 3856 Producer of Sterile Drug Products

IML V 2.25MF/O. IINJECTABLE(b) ( 4 )I .. ·· · · · I . .• I

t I . I

I . I . .. I ', I

I BEVACIZUMAB 0.12 INJECTABLE

D. On 12/ 8/2015 , we observed drug product manipulation activities in the ISO 7 Buffer Room, during this observation we observed . technicians working in a small area which required . technician to stop working and leave the ISO 5 hood each time the technician needed to leave the room. Furthermore, we observed the technicians making frequent trips in and out of the Buffer Room to the Gowning/Prep Room without proper sanitization of

hands. (b) (4) •E. Your firm er your firms "Compounding"

Manager this activity is done in the ISO 5 LFH in the ISO 7 Buffer Room where other drug product manipulation takes place instead of in the ISO 7 WIIJP Room as the Logged Formula Worksheet records require.

Furthermore, the only c leanjng done between products is wiping the area with steril~ F. On 12/8/2015, we observed trash being stored in the ISO 5 LFH during processing this trash is stored between the

• technicians manipulat ing different drug products in a shared ISO 5 LFH.

G.

H. On 12/8/2015 , we observed your Technician and the "Compounding" Manager holding open both the door from the unclassified area to the ISO 7 Gowning/Preparation Room and the door from the ISO 7 Gowning/Preparation room to the ISO 7 Buffer Room where the ISO 5 LFH is located and sterile drug product manipulation activiti es were being performed.

I. On 12/8/2015 during the production of sterile human drug product (Pilocarpine Lot number 20 15 1208@5) we observed your technician reaching over open containers containing sterile solutions and open sterile containers waiting to be filled. Furthermore, your technician ' s forearms are covered with non-sterile gowning.

OBSERVATION 8

Clothing of personnel engaged in the manu facturing and holding ofdrug products is not appropriate for the duties they perform.

Specifically, A. On 12/8/2015, we observed your Technicians during aseptic processing ofsterile human drugs inside the ISO 7

Buffer Room and ISO ~ Laminar Air Flow Hood (LFH), wearing non-steri le gowns and non-sterile hair


EMPI.OYE£(6) SIGNATURE

Shelby N. Marler , Investigator }1A Ademola 0 . Daramola , Investigator ~

01\TE ISSUED

12/29/2015

PAGE 70F 11 PAGESrNSPECTJONAL OBSERVATIONSFORM FDA 433 09101)

DEPARTME~ OF HEALTH AND R UMAN SERVICES

TO : Andrew J . Komuves , President and FIRM HAM£

Dougherty's Pharmacy

Cl • STATl!. ZlP COOE, COUNTIIY

Dallas , TX 75230- 3856

FOOD AND DRUO ADMINISTRATION

Expressway, Suite 300

nets. We observed this practice during the production and filling of the following sterile drug products.

Produce N1me

BEVAC!ZUMAB 0. 12 ML FILL 2SMGJML INJECTABLE

B. On 12/812015, the Tecbnkians had their forehead, eyes, and neck region exposed during aseptic processing (manipulation and filling) of steri le human drugs ( Pilocarpine; lo~ During the performance ofthis sterile operation, they had their foreheads inside the ISO 5 LFH w~no physical barrier between their exposed skin and non-sterile gowning materials and the open Pilocarpin- devices on the LFH work surface.

During thi s time we observed that gowning for sterile operation is inadequate in that

A. Employees wore non-sterile gowns, hair nets, and shoe covers during aseptic processing of sterile drug production in the ISO 5 LFH.

B. Employees', engaged in sterile drug manipulation, eyes and the area around their eyes were left exposed during production of sterile products.

C. Employees facial, neck, and head skin were uncovered and left exposed while working in ISO 5 LFH during production of sterile products.

D. According to your "Compounding" Manager the only gowning requirement for entering the ISO 7 Gowning/Preparation Room is (lDBIJ this area is used for!if~JMIDDD •m•MD·Furthermore, we observed your Technicians don gowns to enter t~l7 B"lil'i'e'rRoom then return to the ISO 7 Gowning/Preparation Room without removing o r replacing gowning items pri or to re-entry into the ISO 7 Buffer Room.

E. Employee's ungloved hands were placed inside the ISO 5 LFH with exposed skin whi!e donning ofgloves in preparation for sterile drug manipulation. Employees enter the ISO 7 Buffer Room and ISO 5 LF H with u ngloved hands. Furthermore, once gloves are donned, technicians move between the ISO 7 Buffer Room and the ISO 7

Room without changing gloves. Non-sterile @I components and in-process materials

EMPLOYE£(8) &IGNATUAE DATE I

Shelby N. Marler, Investigator 8LASEE REVERSE 12/29/2015Ademola 0 . Daramola , Investigator ~ OF THIS PAGE

FORMI'DA4U INSPECTIONAL OBSERVATIONS PAOI! I Of II PAOES

- 12/29/2015*

1000371043


Producer of Sterile Drug Products

- 12/29/2015*

100037104 3 /oc/ indust r

J . Komuves President and CEO

Ph a rmacy

Da l las , TX 7523 0 - 3856 Producer o f Steri l e Dr Prod ucts

OBSERVATION 9

Equipment used in the manufacture, processing, packing or holding of drug products is no t of appropriate design to faci litate operations for its intended use .

Specifically, A. The finn has not conducted equipment qualificati on to show that tiDJIJIIand~used to sterilize

• I I I ;jt ~ I ' . ' sware achieve appropriate log reduction ofmicrobes. The~ anyIIIII (b) (4) - during the sterilization of glassware and Liquid suspensions. Furthermore, the fuiii"'tailed to

ct te tur ping studies of refrigerators and freezers used to store fini shed compounded drugs and II

B. The following equipment lack calibration, validation, and verification of conformance although they are being used - to process, bold, and pack sterile drug products:

a. ization of suspensions. The following suspens ions were sterilized in the

Lot N umber Expiration Date

09/23/2015

09n7/20 15

02/ 1012016

b. depyrogenation of glassware.

c. for sterility and EM samples.

OBSERVATION 10

The distribution system is deficient in that eac b lot of drug product cannot be readily determined to facilitate its recall if

necessary.

Specifically,

Shelby N. Marler , Investigator~ SEE REVERSE 12/29/201 5 Ademola 0 . Da ramola , Investigator f:y? j)OF THIS PAGE

11 PAGES

Finished products are issued lot mrnnher<;

The prescription Labels do

--4040 North Expressway, Suite 300

DEPARTMENT OF HEALTH AND FIUMAN SERVICES FOOD AND DRUG AOMINlSTRATION

12/08/2015 - 12/29/2015* FEI NUMBER

100037104 3

TO: Andrew J . Komuves , President and CEO STREET AllClflESS

Dougherty ' s Pharmacy 5959 Royal Ln Suite 515 TYPE ESTASUSHMENT

Dallas, TX 75230- 3856 Producer of Sterile Dru Products

LotNum~r Oat~ Mad~

061171201 5l (b) (4 ), 06117/2015

0611712015 I I I 0811012015

I 08110/2015

I 06119/201

I 0612212015

Ftll O.t~ on RX La~l

0611612015

06/1 5120150

0810712015

0810812015

061

06119/2015

OBSERVATION 11

Aseptic processing areas are deficient regarding the system for cleaning and d isinfecting the room and equjpment to produce aseptic conditions.

Specifically,

A. Your firm produces an average oalf+atches ofste~using ISO 7 C leanrooms and ISO 5 ~aminar Air Flow Hood (LFH). Your firm uses ~poricidal agent during the [GJIGIJ ~leaning and sanitization of the ISO 5 LFH and ISO 1 cleanroom.

B. Your fiCITl failed to conduct a disinfectant efficacy studies involving the~poricide and other d isinfectants in use at the facility. In addition , there is no defined and establi shed con~ freque ncy of use for the rusin fectants.

OBSERVATION 12

Complaint procedures are deficient in that written complaint records are not maintained in a file designated for drug product complaints.

Specifically, Per your firm 's "Compounding" Manager your firm does not keep records of drug product co mplaints.

* DATES OF INSPECTION: 12/08/2015(Tue), 12/0912015( Wed), 12/10/20 15(Thu), 12/11/2015(Fri), 12/1412015(Mon), 12n2n015(Tue), 12n812015(Mon), 12n912015(Tue)

OATE I DBIPt.OVU(S) SIGNA'1\JR£ (/l fl. Shelby N. Mar ler, Inve stigator ~V \ ~~~ SEE REVERSE 12/29/2015Ademola 0 . Daramola, Investigator ~

OF THIS PAGE

IN PECfiONALOBSERVATIONS PAGE 10 OF I I I'AGES

DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION

04TE(S) Of' INSPECTIONDISTRICT ADORESS AND PHONE NUMBER

12 /08 / 2 0 15 - 12 / 29 / 2 0 1 5* 4040 North Central Expressway, Suite 300 FEI NUMBERDallas , TX 75204

(214) 253- 5200 Fax: (214) 253- 5314 1 0 00371 043 Industry Information : www.fda . gov/oc/industry NAME~ T1T1..E Of' INOIV10UAL TO v.t10M REPORT ISSUED

TO: Andrew J. Komuves, President and CEO FIRM NAME

Dougherty ' s Pharmacy

CrTY, STATE, ZIP COOE, COUNTRY

Dallas , TX 75230- 3856

STREET AOORESS

5959 Royal Ln Suite 515 TYPE ESTABUSHMEHT INSPECTED

Producer of Sterile Drug Products


EMPLOYEE(S)SIGNATURE Shelby N. Marler, Investigator ~ ¥~Ademola 0 . Daramo la , Investigator

04TEISSUED ttpj~12/2 9 / 2015

FORM FDA 483 (09/01) PREVIOUS EDITIONOBSOlETE lNSPECTIONAL OBSERVATIONS PAGE II OF II 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 f ilth, or whereby it may have been rendered injurious to health . A copy of such report shall be sent promptly to the Secretary."

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