483
MARY KAY INC.FDA 483 - MARY KAY INC. - October 27, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 3bc09293-500f-412e-83d3-9a82f2f49994