Denison Pharmaceuticals, LLC
FDA inspection history in Lincoln, Rhode Island, 2016 to 2024
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one Form 483; 2017: one Form 483; 2023: one warning letter and one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17Two Form 483s, at Lincoln, Rhode Island.
- 2023–24Two Form 483s and one warning letter, at Lincoln, Rhode Island.
- 2024The longest 483 on file: 11 observations over 15 pages at Lincoln, Rhode Island.
Cited most
Across all Denison Pharmaceuticals observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.22(d)Responsibilities of quality control unit4
- 21 CFR 211.100(a)Written procedures; deviations2
- 21 CFR 211.165(e)Testing and release for distribution2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
The complete Denison Pharmaceuticals file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Lincoln, Rhode Island
Four Form 483s and one warning letter · 2016 to 2024 · 29 observations
Latest: Form 483, Jul 29, 2024 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-29 | 483 Form 483 | Lincoln, Rhode Island | 11 | $99 |
| 2023-07-26 | Warning letter Warning letter | Lincoln, Rhode Island | — | $99 |
| 2023-02-09 | 483 Form 483 | Lincoln, Rhode Island | 9 | $99 |
| 2017-10-25 | 483 Form 483 | Lincoln, Rhode Island | 1 | $99 |
| 2016-04-05 | 483 Form 483 | Lincoln, Rhode Island | 8 | $99 |
Investigators on these documents
Daniel L. Zheng (2)Jonathan G. Matrisciano (2)Lori M. Newman (2)Ifechimere I. Okafor (1)Nealie C. Newberger (1)Sean R. Marcsisin (1)
FEI number 1210580 · most recent document Jul 29, 2024
About Denison Pharmaceuticals, LLC
How many FDA Form 483s has Denison Pharmaceuticals, LLC received?
FDA Intel has 4 Form 483s on file for Denison Pharmaceuticals, LLC; the most recent is dated Jul 29, 2024.
When was Denison Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Denison Pharmaceuticals, LLC is a Form 483 dated Jul 29, 2024, for the site in Lincoln, Rhode Island.
What did FDA cite at Denison Pharmaceuticals, LLC?
The regulations cited most in the observations on file for Denison Pharmaceuticals, LLC are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.22(d) (Responsibilities of quality control unit), 4 times; 21 CFR 211.100(a) (Written procedures; deviations), 2 times.
Has Denison Pharmaceuticals, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Denison Pharmaceuticals, LLC; the most recent is dated Jul 26, 2023.