- 04 17 2015

3011396023

Folsom, CA 95630-5546 Producer of Sterile Products

TI1is document lists observations made by the FDA representativc(s) during the inspection ofyour facility. They are inspectiona l
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, co rrective action in response to an observat ion, you rnay discuss the object ion or
action with the FDA representative(s) during the inspection or submit thi s infom1ation to FDA at the address above. Jf you have any
questions, please contact FDA nt the phone number and address abo...c.

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:

OBSERVATION 1

Buildings used in the manufacture, processing, packing or holding ofdrug products are not maintained in a clean and sanitary
condition.

Specifically,
On l3Apr 15 during a walk-through inspection, and~ prior to aseptic processing, spatters of
material were observed on the ceiling of the IS0-5 - - LAF hood where aseptic filling occurs;
accord ing to the cleaning log, the hood was in a clean status and cleaned on Friday I OApr 15.

OBSERVATION 2

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room to produce aseptic
condit ions.

Specifically,
A. Non-sterile w ipes are used to clean the IS0-5 LAF hood where aseptic fillin g occurs.
B. Non-sterile and non-lint free mop-heads are used to c lean the IS0-7 anteroom and buffer room
areas that area adjacent to the JS0-5 LAF hood w here aseptic filling occurs.
C. The c leaning procedure provides minimal detai l regarding the technique for cleaning the IS0-5
LAF hood where aseptic filling occurs.
D. No records were available demonstrating the disinfectant solut ion o (b) (4 )

solut ion used to c lean the IS0-5 LAF hood is effe~ughout the solution's
period. Th and sterile ~ are the only two
disinfectants used to clean the IS0-5 LAF hood.
E. Although the formula worksheet fo (b) (4 ) solution states

Linda F. Murphy, Investigator r/..~ 1-.fltvt~

SEE REVERSE
OF THIS PAGE
Daniel J. Robe rts, Investigator ~~ ' 0, 04/17/2015
 DEPARTMENT OF HEALTH AND I IUMAN SERVI CES
FOOD AND DRUG ADMINISTRATION
OISTRICT AOOR.ESS AHO PHON E NUM-SER OATE( S) OF I>ISPECTION

143 1 Harbor Bay Parkway 04/1 3 / 2015 - 04/17 / 20 15

Alameda, CA 94502-707 0
(510) 337-6700 Fax: (510 ) 337-67 02 3011396023
Information: www.fda . ov/oc/industr

TO: Dr. Masoud Rashidi, PharmD, Pharmac

I nnovative Com ounding Pharmacy 820 Wales Dr Ste 3

CITY. STATE. ZIP COOE. COUNTRY TYPE ESTABUSHioiE>IT INSPECTED

Fol som, CA 95630-5546 Producer of Sterile Dru Products

(b) (4) there is no prior cleaning step performed to

remove soil and debris prior to dis infection.
F. Although c lean ing procedure 3.070, "Maintenance of the Ase
walls in the IS0-7 anteroom and buffer areas are cleaned
the Pharmacy Manager stated
clean floors and walls in these areas. No records were available demonstrating this cleaning
agent is effective against spores.

OBSERVAT ION 3

Aseptic process ing areas are de ficient regard ing the system for monitoring environmental conditions.

Specifically,
A. Environmental monitoring for viable and non-viable particulates is never performed during
routine aseptic filling operations. The firm's on ly routi ne environmental monitoring consists of
steri le glove touch plate monitoring. However, th is touch plate monitorin g is performed
inconsistently and not after each aseptic processing filling operation.
B. The pressure differential monitoring gauge between th.e IS0-7 area and the unclassified area is
not continuously monitored or alarmed. In addition,
1. The monitoring gauge is not calibrated.
11. The firm is only monitorin g the di fferential pressure flow from one ( I) o
passage ways from the IS0-7 cleanroom area into adj acent unclassified areas.
111. Pressure monitoring records dated between I 3Jan 15 and 13Apr 15 revealed 65 o .
reco rds where the room d ifferentia l was less than the 0.05 inches of water required by
SOP 3.040, "Environmental Monitoring of Aseptic Compounding Area: Air
Exchange Press ure Differential". Furthermore, 62 ofll of those readings were 5 0.04
inches of water.

OBSERVATION 4

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not fol lowed.

Speci ficall y,
EI.APlOYEE( S) SIGNATURE DATE ISSUED

Li nda F. Murphy , Inves t igator (J~

SEE REVERSE Danie l J . Rober ts , Inv e s t igator \)~~ 0 4 / 1 7/20 1 5
OF T HIS PAGE

FORM FDA 4&l (09108) l 'RLVIOUSt-.Uir JON()I);St.l[.lrrJ~ INSPECTIONAL OBSER VATIONS PAGE 2 OF S PAGES
 DEPARTMENT OF HEALTH AKD HUI\L\N SERVI CES

FOOD AND DRUG ADMINISTRATION

DISTRICT AOORESS AND PHONE NliMBfR DATE{S) Of INSPECTION

1431 Harbor Bay Parkway 04/13/2015 - 04/17/2015

fEI Nt.JMBE:A
Alameda, CA 94502-7070
(510) 337-6700 Fax: (510) 337 - 6702 3011396023
Industr Informat ion: www.fda.gov/oc/industr
NAME AND Tilt OF INOMOUAL TO WHOM REPORT ISSUED

820 Wales Dr Ste 3

T'IPE UTABUS>IMENT INSPECTED

Folsom, CA 95630-5546 Producer of Sterile Dru Products

A. Six (6) of six (6) reviewed fonnula worksheets

injectable products do not include records
However ure 8.030 on
all
In addition, the has not been validated for its intended purpose.
B. The pressure gauge used to demonstrate sterilization is not calibrated.
C. Smoke studies evaluating unidirectional HEPA airflow in the IS0-5 aseptic filling area have
never been performed.
D. Media fill records do not include a record ofthe incubated media fi ll vials; rn addition, there is
no record of incubator temperature during the media fill incubation period.

OBSERVATION 5

Resu lts of stability testing are not used in determining appropriate storage conditions and ex piration dates.

Specifically,
On 15Apr20 15, we observed a 5m l vial of Testosterone Cypionate 200mg/mllot#031 020 15@5 for
injection stored at room temperature that was produced on I 0Mar20 I 5 and assigned a 3-month beyond
use date (BUD) of8Jun2015. Sterility, endotoxin, strength an d purity testing over the BUD has never
been pe1formed for this formulation of steril e injectable product.

OBSERVATION 6

The control systems necessary to prevent contamination or mix-ups are deficient.

Specifica lly,
A. A process is not established to prevent product mix-ups between expired and in-date anticipatory
compounded products; several examples of expired products were observed co-mingled with in
date product anticipatory compounded products were noted.
B. A clear solution with no identifiable contents or expiration date was observed on 13Apr 15 and
lSAprlS in an un ~ray bottle located in the IS0-7 anteroom; the pharmacy manager said
it was non-sterile -

EMPI.OYEE(S) SIGNATURE DATE ISSUED

Linda F. Murphy, Investigator~~

SEE REVERSE
Daniel J. Roberts, Investigator ~~~ 04 /17/2015
OF THIS PAGE

FORM FilA 4Sl (0!111111) INSP ECTIONAL OBSERVATIONS PAGEl OF 5 PAGES

 DE PARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CtSTRICT AOORESS AHC PliONE NUMBER OATE(S) ~INSPECTION

143 1 Harbor Bay Parkway 04/13/2015 - 04/17/2015

FEINUMIIER
Alameda, CA 9450 2 - 7 070
(5 10) 337-6700 Fax : (510) 337-6702 3011396023
Industr Informat ion: www.fda. ov/oc /industr
HMIE AND TITU ~ I>IOMCVAL l O WHOM REPORT I :~SUED

TO: Dr. Masoud Rashidi, PharmD, Pharmac Manager

FIRM HMIE STREET AOORESS

820 wales Dr ste 3

TYPE ESTAOUCHMENT JNSPECTED

Folsom , CA 95630 - 5546 Producer of Sterile Dru Products

C. A disco lored cloth towel was the only hand-drying towel located at the hand washing s ink used
for preparation of non-sterile products.

OBSERVATION 7

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic
conditions.

Specifically,
The ISO 5 and ISO 7 C leanroom are not qualified under dynamic condi tions. For example, dynamic
viable and non-v iable particle monitoring studies ha ve never been performed during qualification. ln
addition. the firm has never evaluated particle counts during use of a (b) (4 )

in the IS0 -7 ante room.

OBSERVATION 8

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

Specifically,
Protective apparel is not worn as necessary to protect drug products fro m contamination. Specifically,
personnel do not wear sterile gowns, hoods, or sterile sleeve cove rs during aseptic processing. In
addition, preparation of steril e prod uct is performed by personnel with exposed skin on their face and
neck.

Each batch ofdrug product purporti ng to be sterile is not laboratory tested to determine conformance to such requirements.

Specifically,
A. Sterility and endotoxin testing is not consistently performed on compounded sterile products. For
examp le,
i. Zero (0) of- lots (0%) of Testosterone Cypionate 200 mg/mL lnj. Soln. produced
between 18Dec 14 and 15Apr 15 were tested for steri Iity or endotox in; the product was
ass igned a beyond use date (B U D) of 90 days from its manufactured date and sto red at
EMF'I.OYEE(SJ SIGNATURE OATEISSUED

Linda F. Murphy, Investigator ~~

SEE REVERSE
Daniel J . Roberts , Investigator ~)~ 04/17/20 1 5
OF THIS PAGE

FORI\I FDA 48J (09/08 rREI'IOUS EDITION UIJMU:r~, INSPECTIONAL OBSERVATIONS PAGE 4 OF S PAGES
 DEPARTMENT OF HEALTH AND H UMAN SERVICES
FOOD AND DRUG ADMINISTRATION
DISTRICT ADDRESS AND PHONE NUMBER DATEjSI OF INSPECTION

1431 Harbor Bay Parkway 04/13/2015 - 04/17/2015

FElNUMBER
Alameda, CA 94502-7070
(510) 337-6700 Fax: (510) 337-6702 3011396023
Industr Information: www.fda. ov/oc/indust
NAiolE ANO TITLE OF INOMDUAI. TOWHOM REPORT ISSOEO

820 Wales Dr Ste 3

TYPE ESTASUSIWaiT INSPECTED

Folsom, CA 95630-5546 Producer of Sterile Dru Products

room temperature.
ii. Eight (8) - 1 1 1 1 1 ofB i-Mix Papavarine/Phento lamine 30mg/2mg/mL Inj. Soln.
produced between 01 Jan IS and 15Aprl5 were tested for steril ity or endotoxin; the product
was assigned a BUD of30 days from its manufacturing date and stored at 2- 8C.
B. Storage periods of finished product not tested for ste~ility consistently exceed the timeframes
required by the Standa rd Operating Procedure (SOP) 1.040, "Pharmaceutical Compounding
Sterile Preparati ons as per USP< 797> ". According to the SOP, in the absence of passing a
sterility test, the storage period for any product prepared from (b) (4 ) , sha ll not

exceed ll days at cold temperature.

For example, Tri-M ix 30 mcg/30mg/2mg/mL Inj. So ln., Lot 012720 15@25, which was prepared
from on 27Jan20 15, was assigned a 30-day BUD and stored at cold
temperature. lt was not tested for sterility.

OBSERVATION 10

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

Specifically,
Six (6) of six (6) reviewed formula worksheets for sterile injectable products did not include a reco rd of
visua l inspection of the finished product.

E>IPLOYEECS) SICNATtJRE DATE ISS<JED

Linda F . Murphy, Investigator ~ "'.).. (Yl.vtA

SEE REVERSE
Daniel J. Roberts, Invest igator ~ ~~ ) 04/17/2015
OF THIS PAGE

FORM fDA 4ll 09101 I:>RE'VJOIJS LlJITION OOSOl.TE INSPECTIONA L OBSE RVATIONS PAGES OF S 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 la~o ratory, 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."