FDA 483 - Palisades Compounding Pharmacy - March 15, 2023

This FDA Form 483 was issued to Palisades Compounding Pharmacy, located at 540 Palisades Dr, Pacific Palisades, CA 90272, a producer of non-sterile drugs. The inspection was conducted from February 23, 2023, to March 15, 2023, by Investigator Darren S Brown. Shahram Soroudi is identified as the owner.

Two observations were made:

1. **Inadequate Segregation and Cleaning for Hazardous Drugs:** The firm produced hazardous drugs without adequate segregation, cleaning of work surfaces, and cleaning of utensils to prevent cross-contamination. Specifically, equipment like the hood, utensils, mortar and pestle, and unguator used for hazardous products were not adequately cleaned, including deactivation of hazardous products, between batches. Examples provided include the dispensing of Progesterone, Estradiol, Bi-Estrogen, Testosterone, and Estriol products without using a deactivator between each product.

2. **Use of Expired Excipients:** The firm released drug product where the strength, purity, or quality was compromised due to the use of expired excipients. Specifically, for Lot# 12262022@ (b)(4) of "Benzocaine 20%/Lidocaine 10%/Tetracaine 10%" produced on December 26, 2022, and filled on January