FDA 483 - MARY KAY INC. - October 27, 2023

An FDA inspection of MARY KAY INC. in Lewisville, TX, a manufacturer of cosmetic and drug products, revealed deficiencies in equipment cleaning and maintenance procedures. The firm failed to establish cleaning validation and did not test for active pharmaceutical ingredient or cleaning product residues prior to use of equipment for products like CC Cream Sunscreen SPF15. This indicates a risk of contamination and non-compliance with good manufacturing practices.