FDA 483 - Coty US LLC - October 27, 2021

An FDA inspection of Coty US LLC in Sanford, NC, revealed significant deficiencies in the manufacturing of hand sanitizer products. The firm failed to follow quality control procedures, lacked proper testing and release protocols, and exhibited poor control over equipment, cleaning, and computerized systems. These issues raise concerns about the quality, purity, and safety of hand sanitizer products distributed to consumers.