# FDA 483 - Denison Pharmaceuticals, LLC - April 05, 2016

Source: https://www.globalkeysolutions.net/records/483/denison-pharmaceuticals-llc/6ef15e97-8d71-4470-b804-13e525c8ed0b

> FDA 483 for Denison Pharmaceuticals, LLC on April 05, 2016. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Denison Pharmaceuticals, LLC
- Inspection Date: 2016-04-05
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Bestcon Pharmaceuticals, LLC, a drug manufacturer in Lincoln, RI, was cited for significant deficiencies in its quality control, laboratory operations, and facility maintenance during an FDA inspection. The firm failed to thoroughly investigate out-of-specification results, maintain data integrity, and ensure proper training and facility upkeep. These issues indicate a systemic lack of adherence to CGMP requirements.

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## Related Officers

- [Nealie C. Newberger](https://www.globalkeysolutions.net/people/nealie-c-newberger/4b7addde-1217-4495-bac2-2f7e3fe2e780)
- [Program Division Director/District Director](https://www.globalkeysolutions.net/people/jonathan-g-matrisciano/17e5bce2-75a6-4182-925d-b94b42763dd2)

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