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