# FDA 483 - Denison Pharmaceuticals, LLC - February 09, 2023

Source: https://www.globalkeysolutions.net/records/483/denison-pharmaceuticals-llc/a5fe71a4-9389-46f4-9317-5e90e0d763eb

> FDA 483 for Denison Pharmaceuticals, LLC on February 09, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Denison Pharmaceuticals, LLC
- Inspection Date: 2023-02-09
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Denison Pharmaceuticals, LLC received a Form 483 citing nine observations related to significant quality control and manufacturing deficiencies. The firm failed to thoroughly investigate numerous product quality complaints, adverse events, and out-of-specification results, including microbial contamination and container closure integrity issues. Additionally, the inspection revealed inadequate validation of test methods and manufacturing processes, poor sanitation practices, and a failure to complete corrective and preventive actions within established timeframes.

## 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)
- [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)
- [483 - 2025-08-26](https://www.globalkeysolutions.net/records/483/denison-pharmaceuticals-llc/e815ef53-8947-42d3-bde7-29507582ed70)

## Related Officers

- [M.S., Consumer Safety Officer at FDA](https://www.globalkeysolutions.net/people/daniel-l-zheng/5e3d993f-654e-4d40-a2c8-69c5e396499f)
- [Deputy Director](https://www.globalkeysolutions.net/people/lori-m-newman/a0e448e4-11ba-4095-b879-feabb8750b3f)
- [Senior Consumer Safety Officer - Pharmaceutical Quality](https://www.globalkeysolutions.net/people/sean-r-marcsisin/45c910a9-9019-4419-9af8-b1c9f3b1e976)

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

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7