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

Source: https://www.globalkeysolutions.net/records/483/cosmetic-essence-llc/2d920fa8-2fe6-43ad-bb2e-c97a89a555c7

> FDA 483 for Cosmetic Essence, LLC. on February 28, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmetic Essence, LLC.
- Inspection Date: 2020-02-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East II
- Summary: 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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## Related Officers

- [Jaison J Eapen](https://www.globalkeysolutions.net/people/jaison-j-eapen/35b16029-11a0-452c-9413-a92dc120c529)

Company: https://www.globalkeysolutions.net/companies/cosmetic-essence-llc/e6718a8c-0a1c-4d84-a91d-392538c07575

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-ii/a9ab7e08-db36-4350-a7d7-6a61dc61250e