# FDA 483 - Denison Pharmaceuticals, LLC - August 26, 2025

Source: https://www.globalkeysolutions.net/records/483/denison-pharmaceuticals-llc/e815ef53-8947-42d3-bde7-29507582ed70

> FDA 483 for Denison Pharmaceuticals, LLC on August 26, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Denison Pharmaceuticals, LLC
- Inspection Date: 2025-08-26
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Denison Pharmaceuticals, LLC in Lincoln, RI, a contract manufacturer of dietary supplements, cosmetics, and human drug products, revealed significant deficiencies. The firm failed to follow written cleaning procedures, maintain its physical plant in a sanitary condition, and ensure proper hygienic practices by personnel. These issues collectively indicate a risk of product contamination.

## Related Documents

- [483 - 2016-04-05](https://www.globalkeysolutions.net/records/483/denison-pharmaceuticals-llc/6ef15e97-8d71-4470-b804-13e525c8ed0b)
- [483 - 2017-10-25](https://www.globalkeysolutions.net/records/483/denison-pharmaceuticals-llc/8581357a-2bb9-4dea-acbe-690a06c6bc36)
- [483 - 2023-02-09](https://www.globalkeysolutions.net/records/483/denison-pharmaceuticals-llc/a5fe71a4-9389-46f4-9317-5e90e0d763eb)
- [WARNING_LETTER - 2023-02-09](https://www.globalkeysolutions.net/records/warning_letter/denison-pharmaceuticals-llc/c2965870-94dc-43e6-b329-b059c7876903)
- [483 - 2024-07-29](https://www.globalkeysolutions.net/records/483/denison-pharmaceuticals-llc/e4e9d792-bf44-4b54-b508-f0b77e37af5c)

## Related Officers

- [Kimberly M. White](https://www.globalkeysolutions.net/people/kimberly-m-white/1d71507a-2e0e-441d-981b-0b5d13968703)

Company: https://www.globalkeysolutions.net/companies/denison-pharmaceuticals-llc/c217e50a-bd7d-49c3-8f66-2bf20a1c71ec

Office: https://www.globalkeysolutions.net/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144
