Denison Pharmaceuticals, LLC
Form 483 issued October 25, 2017 · Lincoln, Rhode Island
- Inspection
- Oct 17 – Oct 25, 2017
- Investigator
- Jonathan G. Matrisciano
- Observations
- 1
- Pages
- 3
- FEI number
- 1210580
In short: On October 25, 2017, FDA issued a Form 483 with 1 observation to Denison Pharmaceuticals, LLC in Lincoln, Rhode Island (FEI 1210580) after an inspection that ran Oct 17 – Oct 25, 2017. The investigator was Jonathan G. Matrisciano. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Jonathan G. Matrisciano
29 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Denison Pharmaceuticals, LLC?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Denison Pharmaceuticals, LLC?
Jonathan G. Matrisciano is named on this Form 483, for the inspection of Oct 17 – Oct 25, 2017. Each investigator has a profile showing what they cite most.
When was Denison Pharmaceuticals, LLC inspected by FDA?
The inspection ran Oct 17 – Oct 25, 2017, and the Form 483 is dated October 25, 2017.
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.