Denison Pharmaceuticals, LLC
Form 483 issued April 5, 2016 · Lincoln, Rhode Island
- Inspection
- Mar 22 – Apr 5, 2016
- Investigators
- Jonathan G. Matrisciano· Nealie C. Newberger
- Observations
- 8
- Pages
- 7
- FEI number
- 1210580
In short: On April 5, 2016, FDA issued a Form 483 with 8 observations to Denison Pharmaceuticals, LLC in Lincoln, Rhode Island (FEI 1210580) after an inspection that ran Mar 22 – Apr 5, 2016. The investigators were Jonathan G. Matrisciano and Nealie C. Newberger. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 6 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
The responsibilities and procedures applicable to the quality control unit…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Laboratory records do not include a complete record of all data secured in the course of…
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Denison Pharmaceuticals, LLC?
FDA listed 8 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Denison Pharmaceuticals, LLC?
Jonathan G. Matrisciano and Nealie C. Newberger are named on this Form 483, for the inspection of Mar 22 – Apr 5, 2016. Each investigator has a profile showing what they cite most.
When was Denison Pharmaceuticals, LLC inspected by FDA?
The inspection ran Mar 22 – Apr 5, 2016, and the Form 483 is dated April 5, 2016.
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.