food and drug administration district address and phone ... · and drug administration district...

DEPARTMENT OF llEALTH AND HUMAN SERVICES FOOD DAND RUG ADMINISTRATION

DISTRICT ADDRESS AND PHONE NUMBER I f

6000 Metro Drive , Suit~ 101 Baltimore, MD 2 1215 (410) 779-5455 Fax : (410) 779-5707 Industry Info r ma tion: www. f da. gov/oc/industry

OA TE(S) Of INSPECTION

09/21/2015 - 10/07/201 5* A;INUMBER

3004562873

NAME ANO TITLE Of INDIVIDUAL TO WHOM REPORT IFEO

TO: Mr. Thomas J . Wilson PharmD., Owner FIRM NAME STREET ADDRESS

1384 Cape Saint Claire Rd

Annapolis , MD 21401 Producer of Sterile and non-sterile d rug p roducts

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

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I DURING AN INSPECTION OF YOUf FIRM WE OBSERVED:

OBSERVATION 1 ,

Procedures designed to prevent : icrobiological cootamr' ation of drug products purporting to be sterile are not established.

Specifically, ~·

On 09/22/20 15, during the prod ction of Glutathione 200mglml Injection, lot II 88208, the following aseptic techniques were 1

observed in the cleanroom: 1

I 1

A) An aseptic operator ~~ observed placing an

bench top inside the ISO 5 LAFH without The operator proceeded to exit the cleanroom fully gowned and walked into the adjacent unclassified area to wash. hands and ~ands with a paper towel before returning back into the unclassified "clean room". Tb.i.iharmacist was then observed putting on sterile gloves. However,.~as observed adjusting the glove with. bare left hand to fit into the glove.

'· B) An aseptic operator~ observed introducing material, such as into

the hood without disinfecting these materials. ! The operator did not r .. ., ........ ,., out of the hood to grab material from shelves that are located in the cleartroom.

C) Another aseptic operator was also observed inh-oducing material into the hood without disinfecting the surface and also not disinfecting! gloves when going b~ck into the hood. This phannacist was producing ALFA-2B I million uniVml ophthalmic.

D) An aseptic operator w observed walking multiple times into and out of the unclassified "clean room" without putting on any appropripte gowning. Additionally, there is no procedure in place for gowning and no gowning instruction in the gownmg area.

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E) The ISO 5 LAFH is hoJsed in an unclassified room.

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SEE REVERSE OF THIS PAGE

FORM FDA~~ (O'J/08)

EMPLOYEE(S) SIGrl\JRE

Nebil A.l Oumer , Investigator Qin Xu, !I nvestigator

'

PRfVIOU$ EDfTIONOBSOLE'T'f! INSPECTIONAL OBSERVATIONS

OATE ISSUEO

10/07/2015

PAGE I OF 6 PAGES

Downloaded from WIZMED.com - Easy to Use Pharma Industry Info

DISTRICT ADDRESS AND PHOI'IE NUMBER

DEPARTMENT 0~ HEALTH AND HUMAN SERVICES FOOD AND DRUG AOMJ'NISTRA TION

0/,TE(S) OF INSPECTION

6000 Metro Drive, Suit e 101 Baltimore, MD 21215

09/21/2015 - 10/07/2015*

(410) 779-5455 Fax: (·flO) 779-5707 Industry Information: ! www.fda . gov/oc/industry NAME AND TITlE OF INOIVlDU.\L TO 'M10M REPORT l SSUEO

FUI'IUMilER

3004562873

ro : Mr. Tho~s J. Wi~s~~P~h~a~r~m=D~-~·~O~w~n~e=r~=-==~-----------------~ FIRM NAME STREET ADDRESS

, Inc . 1

1384 Cape Sal~nit~C~1~a~i~r~e~R~d=-----------i ~~~~~~~~~~~~---------·_,--~~~E~~~~~~~~m~~~~PE~~~

Annapolis, MD 21401

OBSERVATION 2

Producer of Sterile and non-sterile drug products

Procedures designed to prevent l11icrobiological contamination of drug products purporting to be sterile do not include adequate validation of the steriJization process. I

Specifically,

after the sterilization 5 and 8/5115) and Dexamethasone acetate (on

has

ofTriamcinob ne diacetate the product should

stability of the product after

I D) No media fi ll has bee; conducted that s imulatbs routine aseptic operation.

I


EMPlO'Yl;E(S) S! 1\IRE

Nebil At Owner, Investigator Qin Xu, Investigator

INSPECTIONAL OBSERVATIONS

OATE ISSU£0

10/07/2015

PAGE 20F 6 PAGES


DEPARTMENT OF; HEALTH AND HUMAN SERVJCF.S FOOD AND DRUG ADMINISTRATION

6000 Metro Dr ive , Suite 101 Baltimore , MD 21 215 (410) 779- 5455 Fa x: (4 10) 77 9- 5707

0~ TE(S) OF INSPECTION

09/21/2015 - 10/07/2015* FEI NUMBER

3004562873 Industry Informa t ion : , www . fda . gov/oc/~ndustry NAME ANO Tm.E OF INOIVI.DUAL TO 'NHOM REPORT) SSUED

I TO: Mr . Thomas J . Wils on PharmD ., O~ner

FlRMNAME I Cape Ap othecary, Inc .

OBSERVATION 3

STReET AOORESS

1384 Cape Saint Cl aire Rd TYPE ESTABUSHMEHT INSP£CTEO

Producer of Ste r i l e and non- s teri l e d rug p roduct s

Each batch of drug product purporting to be sterile is n t laboratory tested to determine confonnance to such requirements.

Specifically,

A) Mr. TJW stated that sterility/and endotoxin testing sterile products are However, endotoxin test result certificates' of recently products could not be produced by the firm. Mr. TJW stated that endotoxin samples have not been sent to their contract ~ab<>I<ltOl"f for the past 9 months.

conducte~basis.

C) Sterili ty samples are incubated ... ~ ...... .uu in-house; however, the finn did not evaluate the sterility samples using intended to support anaerobic microbes. Furthennore, sterility san1pJc~s is no data that supports the validation of the sterility test.

OBSERVATION 4

on all sterile drug products produced by your ftrm. Instead.

Drug product containers were cleanopt and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use. I

Specifically,

On 09/22/2015, a - used manu that all glassware I beakers are washed with testing is conducted on a - basis wn,PrPin•


e-.oYEE!Sl SIGNA l\JRE I Nebil A. Oumer , I nvestigator Qin Xu , Investigator

OATEISSUEO

10/07/2015

FORM FDA <113 (09/08) PREVIOUS EDITION OBSOLETE INSPECTIONAL OBSERV A:fiONS PAGEJ OF 6PAGES .,


PharmD.,

, Inc . '

21401

OBSERVATION 5 j Aseptic processing areas are de cient regarding the for cleaning and disinfecting the room and equipment to produce aseptic conditions.

Specifically, I

- 10/07/2015*

3004562873

of Sterile and non-sterile drug roducts

The following non-sterile disinfectants are used for san zing the ISO 5 LAFH and the surrounding unclassified "clean No efficacy study was performed to determine if these

level in the ISO 5 LAFH and other surfaces (i.e.

OBSERVATION 6

Clothing of personnel engaged the ih manufacturing processing of drug products is not appropriate for the duties they perform.

Specifically,

On 09/22/2015, two aseptic opebtors were observed .... .rtnnni aseptic operations in the ISO 5 LAFH wearing non-sterile gowning. Specifically, their coat, face mask, shoe and pants were not sterile. Additionally, their face mask did not

COVer their • skin around their rnrPni><Jn

OBSERVATION 7 J

Procedures describing the calib?tion of instruments, gauges and recording devices are not written or followed.

Specifically,

There are no calibration and qualification records for following equipment:

however, no

lncubato ) used for incubating passive air samples, sterility samples and

Additionally, there is no procedure in place for cali and qualification ofthe above listed equipment.


Nebi l A. Oumer , Investi Qin Xu, 1 Investigator

" .

10/07/2015

PAOE 4 Of 6 PAGES


Ann a polis , MD 2 1401

OBSERVATION 8

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

Specifically,

in the IS05 LAFH during aseptic operations.

B) Personnel monitoring is conducted Passive air sampling is conducted on the room" withLAFH, C) An Exp. Date 04/09/2015) used for passive air sampling and for fingertip testing was observed

OBSERVATION 9

Ase.p~ic processing areas are derycient regarding air that is filtered through high-efficiency particulate air filters under pos1t1ve pressure.

Specifically,

operations was conducted on ic conditions. According to Mr.

OBSERVATION 10

There is a failure to thoroughly 1t eview any unexplained and the failure of a batch or any of its components to meet any of its specifications whether or not the batch been already distributed.

- 10/07 /201 5*

of Ste ri l e and non-ster i l e drug

Spedfically, I j

No investigation was initiated to determine the root cause for several potency failure resu Its for products produced in 2013, 20 12 and 2011. For example, Diethysltilbestrol lmg (l~t # 49011 , dated 10/10/13), "Bactroban, Sporonox, Triam, Xylitol" (lot # 20085, dated 5/3 1/12), and Bactroban Nasal Spray 0.2% (lot# 2040103, dated 6/6112) had the following potency results: 80%, 80.5%, and 53.5%1respectively, against a

1pecification o~ Furthermore, there is no procedure in

place for conducting investigati ns.


Nebil AJ oumer , rnvesti j ator Qin Xu , Investigato r

----~----'---------+------- ·- ---

10/07/20 15


DEPARTMENT ~HEALm AND HUMAN SERVICES FOOD DRUG ADMJNJSTRA TION

OISTIIICT AOORESS ANO PHONE NUMBER ' 01\Te(S) ~INSPECTION

' 6000 Metro Drive, Suitle 101 09/21/2015 - 10/07/2015* Baltimore, MD 21215 I'El NUMBER

(410) 779- 5455 Fax: (410) 779- 5707 3004562873 Industry Informat ion : www.fda.gov/oc/'ndustry NAME "-NO T1Tl.E OF INDMOOI\1. TO 'MiOM REPORT ISSUED

TO : Mr. Th.9mas J. Wilson PharmD., Ow ner FIRM NAME i STREET~ESS

Cape Apothecary, Inc. 1384 Cape Saint Claire Rd CITY, STATE, ZJPOCOE. COUN'mV TYPE ESTA.BUSHMEHl' INSPECTED

Annapolis, MD 21401 Producer of Sterile and non - sterile drug products

OBSERVATION 11

There is no written testing program designed to assess t e stability characteristics of drug products.

Specifically,

The finn does not have a stability program for sterile 3IJ d non-sterile drug products manufactured at this site. Hydroxocobalamin (B 12) 3000 MCG/ml injection. Tob ramycin (Ophth) l5mglml Drops and Cisapride 5mglml suspension have an expiration date of 6 months, I month, and 2 me ptbs respectively.

*DATES OF INSPECTION: 0912 1120 IS(Mon ), 09122120 IS(Tue ), 09/28/20 IS(Mon ), 09/2 20 15(Tue ), I 0/06/20 I S(Tue ), 10/07/20 15(Wed)

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EMPI.DVCE(S)SIGHATVRE DATE ISSUED

SEE REVERSE Nebil A. Oumer, Investi gator ~'?a----OF THIS PAGE Qin Xu, , Investigator

~ 10/07/2015

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FORM FDA 483 (09/08) PR.eV10t1S .EDtT10N OBSOt..ET'E INSPECTIONAL OBSERVATIONS PAGE 60F6 PAGES


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