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

Source: https://www.keypedia.com/records/483/cosmetic-essence-llc/3e69c051-94f3-475e-b912-8da2367f8c10

> FDA 483 for Cosmetic Essence, LLC. on March 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cosmetic Essence, LLC.
- Inspection Date: 2025-03-28
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: 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.

## Related Documents

- [483 - 2020-02-28](https://www.keypedia.com/records/483/cosmetic-essence-llc/2d920fa8-2fe6-43ad-bb2e-c97a89a555c7)

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/michael-o-idowu/795647ab-8f6b-47cc-ae88-3b2c61192861)
- [Olumide A. Akinyemi](https://www.keypedia.com/people/olumide-a-akinyemi/a520acd2-450c-4624-a7af-b871e4fad9c7)
- [recipient](https://www.keypedia.com/people/michael-c-brown/b76f558d-c28d-4868-a37c-35e29d16d595)
- [Investigator](https://www.keypedia.com/people/pushpa-s-jayasekara/cfd7d22f-b4c2-4002-ae18-b5435815d27d)

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa