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483
•Cosmetic Essence, LLC.•March 28, 2025

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

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Record Details

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.

Company
Cosmetic Essence, LLC.
Inspection Date
March 28, 2025
Product Type
Drugs
Office
Baltimore District Office
People
  • Michael O. Idowu (issuing_officer)
  • Olumide A. Akinyemi
  • Pushpa S. Jayasekara (Investigator)
  • Michael C. Brown (recipient)
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ID · 3e69c051-94f3-475e-b912-8da2367f8c10

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