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

Westwood Laboratories, LLC. in Azusa, CA, was inspected and cited for significant deficiencies across its quality, laboratory, and production systems. Key issues include a deficient quality control unit failing to investigate complaints and follow CAPAs, inadequate component identity testing, lack of employee training, and unvalidated laboratory methods. The firm also failed to conduct annual product reviews, lacked stability studies, and used unqualified equipment.