Denison Pharmaceuticals, LLC
Form 483 issued February 9, 2023 · Lincoln, Rhode Island
- Inspection
- Jan 5 – Feb 9, 2023
- Investigators
- Daniel L. Zheng· Lori M. Newman· Sean R. Marcsisin
- Observations
- 9
- Pages
- 16
- FEI number
- 1210580
In short: On February 9, 2023, FDA issued a Form 483 with 9 observations to Denison Pharmaceuticals, LLC in Lincoln, Rhode Island (FEI 1210580) after an inspection that ran Jan 5 – Feb 9, 2023. The investigators were Daniel L. Zheng, Lori M. Newman and Sean R. Marcsisin. Most observations concern production and quality system.
At a glance
Production and quality system account for 5 of 8 observations.
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
Drug product component testing is deficient in that at least one specific test to verify the…
- 03
The accuracy, sensitivity, specificity and reproducibility of test methods…
- 05
Procedmes designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
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 9 observations on this Form 483, mostly about production, quality system and materials. The opening words of each observation are shown on this page.
Who inspected Denison Pharmaceuticals, LLC?
Daniel L. Zheng, Lori M. Newman and Sean R. Marcsisin are named on this Form 483, for the inspection of Jan 5 – Feb 9, 2023. Each investigator has a profile showing what they cite most.
When was Denison Pharmaceuticals, LLC inspected by FDA?
The inspection ran Jan 5 – Feb 9, 2023, and the Form 483 is dated February 9, 2023.
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.