FDA 483 - Cosmetic Essence, LLC. - March 28, 2025

An FDA inspection of Cosmetic Essence, LLC. in Roanoke, VA, a manufacturer of OTC drug products, revealed nine significant observations. The firm was cited for deficiencies in laboratory controls, equipment maintenance, data integrity, and quality unit responsibilities. These issues indicate a systemic failure to adhere to good manufacturing practices, potentially impacting product quality and safety.