# FDA 483 - Denison Pharmaceuticals, LLC - July 29, 2024

Source: https://www.keypedia.com/records/483/denison-pharmaceuticals-llc/e4e9d792-bf44-4b54-b508-f0b77e37af5c

> FDA 483 for Denison Pharmaceuticals, LLC on July 29, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Denison Pharmaceuticals, LLC
- Inspection Date: 2024-07-29
- Product Type: drugs
- Office Name: New England District Office
- Summary: An FDA inspection of Denison Pharmaceuticals, LLC in Lincoln, RI, a human drug manufacturer, revealed significant deficiencies in quality control, facility maintenance, and production processes. The firm failed to adequately investigate numerous discrepancies, including OOS/OOT results, mold, and microbial contamination, and exhibited poor control over GMP documents, materials, and labeling. Additionally, the facility showed issues with cleanliness, pest control, and equipment maintenance, indicating a systemic lack of adherence to cGMP regulations.

## Related Documents

- [483 - 2016-04-05](https://www.keypedia.com/records/483/denison-pharmaceuticals-llc/6ef15e97-8d71-4470-b804-13e525c8ed0b)
- [483 - 2017-10-25](https://www.keypedia.com/records/483/denison-pharmaceuticals-llc/8581357a-2bb9-4dea-acbe-690a06c6bc36)
- [483 - 2023-02-09](https://www.keypedia.com/records/483/denison-pharmaceuticals-llc/a5fe71a4-9389-46f4-9317-5e90e0d763eb)
- [WARNING_LETTER - 2023-02-09](https://www.keypedia.com/records/warning_letter/denison-pharmaceuticals-llc/c2965870-94dc-43e6-b329-b059c7876903)
- [483 - 2025-08-26](https://www.keypedia.com/records/483/denison-pharmaceuticals-llc/e815ef53-8947-42d3-bde7-29507582ed70)

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.keypedia.com/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Deputy Director](https://www.keypedia.com/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)
- [investigator](https://www.keypedia.com/people/ifechimere-i-okafor/c48399bf-47d9-4562-9130-1e6731eca07d)

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

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