DEPARTMENT OF HEALTH AND UUMAN SERVICES

fOOD AND DRUG ADMINISTRATION

DISTRICT ACORESS AND PHONE NUMBER DATE($) OF INSPECTION

io Waterview Blvd., 3rd Floor . 3/3/2016~4/15/2016*

Parsippany, NJ 07054 FEINVMSER

(973)331-4900 Fax:(973)331-4969 3012223534

NA111E AND TITLE OF INOMCUAL TO~ REPORT ISSUED

Svetislav Milic, R.Ph. , Owner

FIRM NAME STREET ADDReSS

Colonia care Pharmacy 515 :tnt!lan Ave Ste A

CITY, STAll:, ZIP CODe, COUNTRY TYPE ESTASl.ISHMENT INSPECTED

Colonia, NJ 07067-1114 Producer of Sterile Drug Products

This document lists observations made by the FDA representativc(s) during tile inspection of your facility. They are J~:~spectional
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 disc.uss.the objection or
action with the FDA representative(s) during thejnspection or submit this information 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 1OBSERVED:

OBSERVATION l
There is ~o written testing program designed to assess the stability characteristics of.drug products.

Specifically, there is insufficient test data supporting the labeled Beyond Use Date (BUD) .provided for
some injectable products or inprocess sterile-filtered stock solutions used to :prepare them. For
example: ,

Papaverine/Phentolamine/Prostaglandin-E I ll1iection Solution ("Trimix"), lot 020216A, Was

prepared and filled on 2/2/16 in a multi-use vial, with a sun. of 30 days refrigerated, ~d 6
months when frozen. The finished product was not tested for sterility, and was made using in
house stock solutions prepared from non-sterile Starting materials, one of which was expired
(Papaverine stock solution expired approx. 23 day~ earlier, on 1/10/2016).

a
Each stock injection solution was prepared in multiuse vi~, and assigned a BUD of 1 to 6
months after filter sterilization, and stored in an unclassified area (Papaverine stock solution
produced on 12/11115, BUD 01/10116; Phentolamine stock solution produce9 on 1,2/03/15, BUD
05/31/16; and Alprostadil stock solution produced on 12/11/15, BUD 06/08/16).

No data was provided demonstrating these stock solutions or finished sterile drug product have
been evaluated for potency, purity, sterility, or endotoxin levels at the end of their labeled BUDs.
The stock solutions may contain preservatives, but their effectiveness over the labeled BUDs in
mu1ti~use vials has also not been assessed.

Methylcobalamin and Acetylcysteine Injection Solution, lot 120715M, was prepared and fiUed
on 12/07/15 in pre-filled syringes, with' a BUD of 30 days refrigerated, and 6 months when

EMPlO'IEE(S) $1GNATUAE llAtE !SSUEO

SEE REVERSE Nicholas A. Violand, Invstigator 4/15/2016

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FORM FDA 413 (OJ{j)S) I'RE\10US eomo>1 oosm..ETE INSPECI'IONAL ODSERVATIO~S PAOI! I OF 4 PAGES
 DEPARTMENT OF HEALTH AND HUMAN SERVICES
' FOOD AND DRUG ADMINISTRATION
DISTRICT ACID!II!SS ANOPHONE NUMBER OATE(S) 01' INSPECTION

10, Waterview Blvd., 3rd Floor 3/3/2016-4/15/2016*

FEINVMBER
Parsippany, NJ 07054 3012223534
(~73)3~i~4900 Fax: (973)331-4~69

NAME AND TlfL!S OF INOIVIPUA~ 'TO WHOM REPORT I$S!JEO

Sveti.slav Mil'ic, R.Ph. 1 owner

-sTRI$ ADDRESS

Colonia Care Pharmacy 515 Inman Ave Ste A

CITY, STA'I'E, ZIP ...,.,ti,-<::OVNTRY TYPE ES A~t<>HMENT INSPECTED

~olonia,. N~ 07067-1114 Producer of Sterile Drug Products

.frozen. The finished product was not tested for sterility, and was made from an in-house stock
solution, with BUD 04/0S/16 (prepared 10/08/15), which is stored in an unClassified area. No
data was provided demonstrating the stock solution or finished sterile drug product have been
evaluated for potency, purity, sterility, or endotoxin levels at the end of their labeled BUDs,;or
that the container-closure system (syringes) used for the finished drug product is suitable for its
intended use.

Dexamethasone 24mg/ml Injectable, lot 031716N, was aseptically filled on 3/17/2016, with
instructions to provide a BUD of "45 days after compounding date" but was labeled "06/0l/16
Frozen~\ instead of the specified "5/1/2016;' in the record. There was no sterility, potency;
purity, or endotoxin testing performed to support the labeled BUD.

OBSERVATION 2
Testing and release of drug product for distribution do not include appropriate laboratory determination
of satisfactory .conformance to the final specifications and identity and strength of each active ingredient
prior to release.

Specifically, not all finished sterile drug products are tested for sterility and endotoxin levels, where
appropriate, and thete is notesting schedule. For example:

Papaverine/Phentolamine/Prostaglandin-EI Injection Solution ("Trimix"),lot 020216A, was

prepared and filled on 2/2/16, and given a BUb of30 days refrigerated, and 6 months when
frozen. There was no testing of sterility or endotoxin levels of the finished drug product.

Methylcobalamin andAcetylcysteine InJection Solution, lot 120715M, was prepared and filled
on.l2/07/15, and given a BUD of30 days refrigerated, and 6 months when frozen. There was .no
testing of sterility or endotoxin levels of the finished drug product. '

Atropine Ophthalmic Solution, lot 0203161, was prepared and filled on 02/03/16, and given a
BUD of 3 months. There was no testing of ste.rility of the finished drug product.

EMPI.OYEE(S) ~A TUR1! OA'I'E ISSUI!O

SEE REVERSE Nicholas .A Violand, Investigator ~"''"' 4/J.S/2016

OF THIS PAGE

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I.NSPECTlONAL OBSERVATIONS
 DEPARTMENT OF HEALTil AND HOMAN SERVICES
1'000 AND QRUG ADMTNISTRATION
DISTRIC ADOFIIOSO AND PHONe: IIVMB1:R OATE(S) OF INSPECllCOI

10 Waterview Blvd., 3rd Floor 3/3/2016~~/15/2016*

EIN\IMBER
Parsippany, NJ 0705'4
{973) 331-4900 Fax: (973) 331-4969 3012223534

W.ME~TITU!OF INDIVIDUAL TO WHOM REPORT ISSU0

Svetislav Milic, R.Ph. , Owner

F'IRM_NA10.1<1 STREHAOORESS

Colonia Care Pharmacy 515 Inman Ave Ste A

CITY, STATl!. ZIP COllE, COUNTIW TYPE ESTAli.LISHMENT INSPECTED

Colonia, NJ 07067-1114 Producer of Sterile Drug, .Products

Hydrogen Peroxide Injectable, lot 010516G, was prepared and filled on 01/05/16, and :given a
BUD of 1 month. There was no testing of sterility or endotoxin levels ofthe.finished drug
prod':~ct.

OBSERVATION 3 f
Aseptic processing areas are deficient ~egarding the system for monitoring environmental conditions.

Specifically, in the laminar flow glovebox, which is located in an unclassified room and is used for
aseptic filling of sterile drug products, the evaluation of unidirectional airflow continuity ,(e.g., smoke
studies), airborne viable and nonviable particle counts, and surface monitoring for microbiQlogical
contamination are not performed under dynamic conditions that represent routine usage,

The .air and surface monitoring are performed twice annually during recertification c,>f the laminar flow
glovebox when it is not being used, and not .routinely during aseptic filling, which may occur daily or '
multiple times throughout the week. In addition, personnel monitoring consists <>f gloved fingertip
monitoring (sterile gloves are donned over the gauntlet-gloves) every six months, and is performed as an
. independent operation, itot after completion of aseptic fiiling,.to represent routine conditions.

OBSERVATION 4
Procedures designed to prevent microbiological contamination of drug products purporting tobe sterile
do not 'include validation of the sterilization process.

Specifically, twice-annual media fill testing is performed to support aseptic filling p111ctices, in which
l 00m1 of soybean casein digest media is prepared, sterile filtered, and filled into an unspecified number
of" 10 ml" vials, with a 5 m1 control sample. This does not represent the most challenging conditipns,jn
that up to 30 vials may be -filled at one .time. F.or example, Dexamethasone 24mg/ml 'Injectable, .lo~
0317l6N, was prepared onJ/17/16, and filled into 30 vials.

OBSERVATION 5
Container closure systems do not provide adequate protection against foreseeable external factors in
storage and. use that can cause deterioration or contamination of the drug product.

~MPLOYEE(S) SIGNATlJRE OAtE ISS \JED

SEE REVERSE Nichola~ A Violand, Investigator ~~ 4/15/~016

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FORM FDA 483 {09/08) PREVIOUS a>mO:< OBSOLEffi INSPECTIONA LOBSERVATIONS PAOIH OF 4 !'AGES
 DEPARTMENT OF IJEALTH AND HUMAN SERVICES
. FOOD AND ORUGADMINIS!RA TION
DIST~C.T,o\~ORESSAN!l PHONe NUMBER DATI::{S).OF INSPECTION

1.0 .Waterview Bl'Vd., Jrd Floor 3/3/2 016~4/lS/2016*

FI!INUMB!!R
:Parsippany, NJ 07054
3012223534
(97l}ja_i'..i:'9oo Fax: (973)331-4969
NAME AND ITl.l! OF INOiviDUAI. ' " WJ1<.1M REPORT ISSUED

svet:Lslav Milic, :R.Ph. , Owner

.STREET AOORESS

Colorii~ Care Pharmacy sis Inman Ave Ste A

CITY, STAn:, ZlPCODE, COUNTRY TYPI; ESTABIJSHMENT INSPECTED

Colonia, NJ 070'67-1114 Producer of Sterile Drug Products

Specifically, the filling record for Papaverine/Phentolamine/Prostaglandin-El Injection Solution~ lot

0202'16A; executed 2/2116~ notes "Protect from light'\ but the finished drug product is preparedin ":lOml
CJear. Sterile vial". There is no assurance the drug is adequately protected fromlight.

*DATES OF INSPECTION .
3/03/2016(Thu),3/07/20 16(Mon)~3/21/20 l6(Mon), 4/04/20 16(Mon),4/06/20 16(Wed),4/08/20 16(Fri),4/l5
, /20l6(Fri)

EMPI.OV!iE{S) SIONATURE OATelSSUEi>

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4/15/2016

lNSPECTIONAL OBSERVATIONS