FDA 483 - Westwood Laboratories, LLC. - October 31, 2024

Westwood Laboratories, LLC. in Azusa, CA, was inspected and received a Form 483 with six observations. The inspection revealed significant deficiencies in quality control, including inadequate investigations into out-of-specification results, a lack of a comprehensive stability testing program, and insufficient controls over computer systems. Additionally, the firm failed to establish adequate process validation, and did not properly test drug product components for identity, purity, strength, and quality.