FDA 483 - Weckerle Cosmetics USA, INC - March 26, 2021

Weckerle Cosmetics USA, INC in Torrance, CA, was inspected and received nine observations related to significant deficiencies in their quality control, record-keeping, equipment maintenance, and laboratory systems. Key issues include a lack of investigations into failed tests, inadequate annual product reviews, insufficient supplier qualification, and poor data integrity controls for analytical equipment. These findings indicate a broad failure to adhere to good manufacturing practices for drug products.