Westwood Laboratories LLC – FDA Warning Letter, Nov 20, 2023

On April 17, 2024, the FDA issued a Warning Letter to Westwood Laboratories LLC, following an inspection from October 30 to November 20, 2023. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated.

Key violations include: 1. **Inadequate Investigations (21 CFR 211.192):** The firm failed to thoroughly investigate complaints for OTC drug products. Their response was insufficient, lacking supporting documentation for procedural changes and a commitment to evaluating the Quality Unit's (QU) processes for effective CAPA. 2. **Insufficient Component Testing (21 CFR 211.84(d)(1) and 211.84(d)(2)):** The firm failed to test propylene glycol for diethylene glycol (DEG) and ethylene glycol (EG) and relied on supplier COAs without adequate validation. Their response lacked detail, evidence, and retrospective testing plans. 3. **Deficient Laboratory Controls (21 CFR 211.160(b)):** The firm lacked appropriate controls over their HPLC software (e.g., employee logins, audit trails, validation documentation) and failed to verify revised microbial testing methods using rapid detection plates, which were intended for the food industry. 4. **Inadequate Production and Process Controls (21 CFR 21