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DR 3 Southerncaliforniacompoundingpharmacyllc

The FDA conducted an inspection of Southern California Compounding Pharmacy from July 8 to August 1, 2019, and noted several deficiencies in their practices, including inadequate personnel monitoring, gowning and aseptic practices, and cleaning procedures. Observations included failure to perform growth promotion for media, inadequate smoke studies for airflow, and lack of microbiological testing for non-sterile drug products. The report serves as a preliminary notice of objectionable conditions and does not represent a final compliance determination.

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15 views3 pages

DR 3 Southerncaliforniacompoundingpharmacyllc

The FDA conducted an inspection of Southern California Compounding Pharmacy from July 8 to August 1, 2019, and noted several deficiencies in their practices, including inadequate personnel monitoring, gowning and aseptic practices, and cleaning procedures. Observations included failure to perform growth promotion for media, inadequate smoke studies for airflow, and lack of microbiological testing for non-sterile drug products. The report serves as a preliminary notice of objectionable conditions and does not represent a final compliance determination.

Uploaded by

aibn
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

DISTRICT OFFICE ADDRESS ANO PHONE NUMBER DA'TE(S) OF INSPECTION

19701 Fairchild 7/8/2019 - 8/1/2019


Irvine, CA 92612-2445
FEINUMBER
(949)608-2900 Fa~:(949)608-4417
3010006900
Industry lnfonnation: www.fda.gov/oc/industry
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED

TQ; Mark J. Badria, Pharmacists in Charge/Co-Owner


FIRM NAME STREET ADDRESS

Southern California Compounding Pharmacy, LLC 11125 Flintkote Avenue Suite F


CITY, STATE AND ZIP CODE TYPE OF ESTABLISHMENT INSP.ECTED
San Diego, CA 92121 Producer of Sterile and Non-Sterile Drug Products
THIS DOCUMENT LISTS OBSERVATIONS MADE BY THE FDA REPRESENTATIVE(S) DURING THE INSPECTION OF YOUR FACILITY. THEY ARE INSPECTIONAL
OBSERVATIONS; AND 0 0 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 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 ADDRESS ABOVE.
DURING AN INSPECTION OF YOUR FIRM (I) (WE) OBSERVED:

OBSERVATION 1
Personnel and environmental monitoring conducted within the ISO 5 Environments on a (15) (4) frequency are
deficient.

Specifically, your firm does not perform growth promotion for each batch of media purchased or use a positive
control when conducting 6 4 gloved finger assessment and surface sampling. Your firm conducts gloved
fingertip test and surface sampling as part of the compounding personnel qualification.

OBSERVATION 2
Gowning and aseptic practices are deficient.

Specifically, during the aseptic operation for Rx# 15 6 on 7/10/19, we observed operator's head enter the
ISO 5 Laminar Airflow Workstation (LAFW) during aseptic operations with exposed skin on forehead and
cheeks. In addition, operator's skin was exposed at the ankle during aseptic operations and lower back skin was
exposed during 15 4 cleaning of the ISO 7 Buffer room.

OBSERVATION 3
The firm's cleaning and disinfecting procedure in the aseptic processing area are deficient.

Add Contlnuation Page

RE EMPLOYEE(S) NAME ANO TITLE (Prin t or Type) DATE ISSUED


SEE
REVERSE
OF THIS Santiago Gallardo Johnson, Investigator 08/01/2019
PAGE

INSPECTIONAL OBSERVATIONS Page 1 of2


DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

DISTRICT OFFICE ADDRESS AND PHONE NUMBER DATE(S) OF INSPECTION

I 970 I Fairchild 7/8/2019 - 8/1/2019


Irvine, CA 92612-2445
FEI NUMBER
(949)608-2900 Fax:(949)608-4417
3010006900
Industry Information: www.fda.gov/oc/industry
NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT IS ISSUED

TQ: Mark J. Badria, Ph,mnl'cists in Charge/Co-Owner


FIRM NAME STREET ADDRESS

Southern California Compounding Phannacy, LLC I I I25 Flintkote A venue Suite F


CITY, STATE AND ZIP CODE TYPE OF ESTABLISHMENT INSPECTED

San Diego, CA 92l21 Producer of Sterile and Non-Sterile Drug Products

Specifically,
Your firm uses non-sterile wipes sprayed with I (6) (4) to wipe components prior to introduction into the
ISO 5 Laminar Airflow Workstation (LAFW) and to clean ISO 5 LAFW counter top where the sterile drug
products are prepared. On 7/10/19, during sterile compounding of Rx #, (6) (6~;, operator was observed moving
items staged on the ISO 7 buffer room storage table to the ISO 5 LAFW without first sanitizing the items with
~ (b)(4)

In addition your finn utilizes the following non-sterile products to clean the ISO 5 LAFW:
(b) (4)

OBSERVATION 4
Smoke study conducted on 6/21/2019 to determine unidirectional airflows in ISO 5 LAFW was inadequate.

Specifically, the smoke study failed to adequately simulate dynamic conditions and did not provide adequate
coverage to demonstrate unidirectional air flow during routine operations. ISO 5 LAFW is where the finn
produces all its sterile drug products.

OBSERVATION 5
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications,
sampling plans, and test procedures designed to assure drug products confonn to appropriate standards of identity,
strength, quality and purity.

Specifically, finished non-sterile drug products are not tested for the presence of microorganisms, for example:
Ketoprofen 20%/Lidocaine 10%, lot no. 07419K20L10A, submitted for l (6f(4] process validation sample did
not include a test for the presence of microorganisms.

0
SEE
REVERSE
tf/Jt
6EMPLOYEE~?-§ ~

,",',
N 1RE

w
!,

,I •
~><
· _,/
/L
/
.-EMPLOYEE(S) NAME AND TITLE (Prfnt or Type)

Santiago Gallardo Johnson, Investigator


Add.ContinuatJon Page
DATE ISSUED

08/01/2019

FORM FDA 483 9/08 PREVIOl!fS EDITION OBSOLETE'---" INSPECTIONAL OBSERVATIONS Page 2 of2
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."

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