# FDA 483 - Denison Pharmaceuticals, LLC - October 25, 2017

Source: https://www.globalkeysolutions.net/records/483/denison-pharmaceuticals-llc/8581357a-2bb9-4dea-acbe-690a06c6bc36

> FDA 483 for Denison Pharmaceuticals, LLC on October 25, 2017. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Denison Pharmaceuticals, LLC
- Inspection Date: 2017-10-25
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Denison Pharmaceuticals, LLC in Lincoln, RI, was inspected by the FDA from October 17-25, 2017. The inspection identified a significant deficiency in the firm's Quality Control Unit, which failed to consistently follow its established procedures for handling customer complaints and adverse events. This indicates a breakdown in critical quality system processes related to complaint management.

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## Related Officers

- [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