FDA 483 - Avon Manufacturing (Guangzhou) Ltd. - December 01, 2023

An FDA inspection of Avon Manufacturing (Guangzhou) Ltd., an OTC human drug and cosmetic manufacturer, revealed significant deficiencies in data integrity, record-keeping, and quality control. Repeat observations included inadequate computer system controls for analytical data and falsified cleaning records. The firm also failed to follow written procedures for change control and conduct thorough investigations into product discrepancies and out-of-specification results.