DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER 

19701 Fairchild 

I rvine, CA 92612- 2 44 5 

(9 49)608- 2900 Fax : (9 49) 608-44 17 

OATE(S) OF INSPECTION 

2/23/2023- 3/15/2023* FEJNUMBER 

3008174851 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Shahram Soroudi, Owner 

FIRM NAME 

Palisades Compounding Pharmacy 

STREET ADDRESS 

540 Palisades Dr 

CITY. STATE. ZIP CODE. COUITTRY 

Pacific Palisades, CA 90272 

TYPE ESTABUSHMENT INSPECTED 

Producer of Non- St erile Drugs 

This document lists observations made by the FDA representative(s) during the inspection of your facility. They are inspectional 

observations, and do not represent a final Agency detemiination 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 subrit this infonnation 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 OBSERVED: 

OBSERVATION 1 

You produced hazardous drngs without providing adequate segregation, cleaning of work surfaces and 

cleaning of utensils to prevent cross-containination. 

Specifically, the hood, utensils, mortar and pestle, unguator and other equipment used to produce 

hazardous products are not adequately cleaned, to include the deactivation of hazardous products, 

between batches to prevent cross-containination. 

For example, your fnm dispensed prescriptions for Rx~bns,.(bmxcl, Progesterone (50 mg) capsules; Rx# 

rns,. (bf(7)(C

1 t) {b)l6) b) '.(li)l6f.llif(71fC , Progesterone (200 mg/~ cream; Rx~ ·, 

)(C~ Estrad10• l (8 mg/gm). cream; Rx# I , • j >
. (b) 11><cl >TTs1. 11>TC1><crl 1 

Bi-Estrogen (3.5 m~gm)Jel· Rx# , Testosterone (9 Ill~tW,IJ cream; Rx Testosterone 

(2 mg/gm) gel; Rx~6 6 

H . (b mcj Estriol (2 mg/gm) cream; Rx~bllS,(bJ 7 

c1 Estriol (5 mg/gm) cream on your 

fnm's equipment without using a deactivator between each product produced. 

OBSERVATION 2 

Your fnm released diug product in which the strength differs from, or its purity or quality falls below, 

that which it purports or is represented to possess. 

Specifically, your fnm used the following expired excipients in the production of the finished di11_g .. 

product with . lot# 12262022@[ ltiH•I produced on 12/26/2022 and filled on 1/18/2023 for Rx # : rns,. lti) (7RC1 

Benzocaine 20%/Lidocaine 10%/Tetracaine 10%" with an expily/use by date of 06/26/2023 : 

a!{b ( 4) I Lot # [(b) ( 4 )I, expiration 12/25/2022 

EMPLOYEE(S) SIGNATURE DATE ISSUED 

SEE REVERSE Darren S Brown, I nvest igat or 

OF THIS PAGE 

X 

~ ~03- · 

3/1 5/2023 OarrenS6KM'l'I 

200164ns0 

15-2023 1233 

of2 FORM FDA ~83 (09/08) INS PAGE I PAGES PREVIOUS EDmON OBSOLEJE PECTIONAL OBSERVATIONS 
FORM FDA ~83 (09/08) PAGE 2 of2 PAGES PREVIOUS EDmON OBSOLEJE INSPECTIONAL OBSERVATIONS 

DEPARTMENT OF HEALTH AND HUMAN SERVICES 

FOOD AND DRUG ADMINISTRATION D ISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 

19701 Fairchild 2/23/2023- 3/15/2023* 

Irvine, CA 92612- 244 5 FEJNUMBER 

3008174851 (949) 608- 2900 Fax: (949) 608-44 17 

NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED 

Shahram Soroudi, Owner 

FIRM NAME STREET ADDRESS 

Palisades Compounding Pharmacy 540 Palisades Dr CITY. STATE. ZIP CODE. COUITTRY TYPE ESTABUSHMENT INSPECTED 

Pacific Palisades, CA 90272 Producer of Non- Sterile Drugs 

tj(b ( 4) I, Lot # [(b) ( 4 )l, expiration 10/24/2022 

*DATES OF INSPECTION 

2/23/2023(Thu), 2/27 /2023(Mon), 2/28/2023(Tue ), 3/03/2023(Fri), 3/09/2023(Thu), 3/10/2023(Fri), 

3/15/2023(Wed) 

SEE REVERSE 

OF THIS PAGE 

EMPLOYEE(S) SIGNATURE 

Darren S Brown, I nvestigat or OarrenS6KM'l'I 

~ r200164ns0 

X 1233"fr" ... ,s-= 

DATE ISSUED 

3/15/2023 
 

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 

judgment, 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."