FDA 483 - Cosmetic Essence, LLC. - February 28, 2020

An FDA inspection of Cosmetic Essence, LLC. in Roanoke, VA, revealed significant deficiencies in its manufacturing processes for over-the-counter drug products. Observations included a repeat finding regarding inadequate investigations into unexplained discrepancies, insufficient reprocessing procedures, and improper sampling criteria for raw materials. These issues indicate a need for improved quality system controls and adherence to established standards.