Denison Pharmaceuticals, LLC
Form 483 issued July 29, 2024 · Lincoln, Rhode Island
- Inspection
- Jun 17 – Jul 29, 2024
- Investigators
- Daniel L. Zheng· Ifechimere I. Okafor· Lori M. Newman
- Observations
- 11
- Pages
- 15
- FEI number
- 1210580
In short: On July 29, 2024, FDA issued a Form 483 with 11 observations to Denison Pharmaceuticals, LLC in Lincoln, Rhode Island (FEI 1210580) after an inspection that ran Jun 17 – Jul 29, 2024. The investigators were Daniel L. Zheng, Ifechimere I. Okafor and Lori M. Newman. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
Drug product production and control records, are not reviewed and approved by the quality control unit…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Daniel L. Zheng
24 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmDenison Pharmaceuticals, LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Denison Pharmaceuticals, LLC?
FDA listed 11 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Denison Pharmaceuticals, LLC?
Daniel L. Zheng, Ifechimere I. Okafor and Lori M. Newman are named on this Form 483, for the inspection of Jun 17 – Jul 29, 2024. Each investigator has a profile showing what they cite most.
When was Denison Pharmaceuticals, LLC inspected by FDA?
The inspection ran Jun 17 – Jul 29, 2024, and the Form 483 is dated July 29, 2024.
How do I get the full Form 483 for Denison Pharmaceuticals, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.