Westwood Laboratories LLC

Warning LetterOpen

Mr. Paul A. Schirmer Chief Executive Officer Westwood Laboratories LLC 710 S. Ayon Avenue Azusa , CA 91702 United StatesFEI 2020372Issued Apr 17, 2024Division of Pharmaceutical Quality Operations IV

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 2020372.

Violations5

Issue DateApr 17, 2024

Product TypeDrugs

StatusOpen

Letter Details

Firm: Westwood Laboratories LLC
Location: Mr. Paul A. Schirmer Chief Executive Officer Westwood Laboratories LLC 710 S. Ayon Avenue Azusa , CA 91702 United States
FEI Number: 2020372
Country: United States
Issue Date: April 17, 2024
Issuing Office: Division of Pharmaceutical Quality Operations IV
Product Type: Drugs
Status: Open

Summary

Westwood Laboratories LLC, a drug manufacturer in Azusa, California, was cited for significant Current Good Manufacturing Practice (CGMP) violations in its production of over-the-counter pharmaceutical products, rendering them adulterated. The company failed to adequately investigate product complaints and quality failures, such as a batch of Advanced Protection SPF 30 that separated, and did not properly review manufacturing records or evaluate processing parameters before taking corrective action. Notably, the firm reprocessed a defective lot, assigned it a new expiration date, and released it without adequate investigation—demonstrating systemic failures in batch investigation and quality control procedures required under 21 CFR 211.192.

Westwood Laboratories LLC FDA Warning Letter, April 17, 2024