FDA 483 - Westwood Laboratories, LLC. - November 20, 2023

During an FDA inspection from October 30 to November 20, 2023, Westwood Laboratories, LLC., a contract manufacturer in Azusa, CA, received a Form FDA 483 detailing significant quality system deficiencies. Observations highlighted a lack of adequate quality control unit authority, with the firm failing to thoroughly investigate consumer complaints regarding product quality (e.g., watery or separating products) and not properly addressing previous corrective actions, including unactivated audit trails on critical analytical equipment. The inspection also revealed failures in verifying the identity of incoming drug components and monitoring the manufacturing water system for microbial and conductivity levels. Furthermore, contract employees performing drug compounding, filling, and micro-operations lacked essential cGMP training. Record-keeping issues included overdue annual product reviews. In the laboratory, microbiological test methods were found to be unvalidated and unsuitable for drug products, with raw data being recorded on uncontrolled, loose-leaf paper. The company also lacked ongoing stability studies to support product expiration dates. Lastly, the production system suffered from an unqualified water system and cleaning/sanitation monitoring equipment, with data loss noted. These observations indicate a need for comprehensive corrective actions to ensure compliance with current Good Manufacturing Practices (cGMP) and maintain drug product quality and safety.