Purdue Pharmaceuticals L.P.
Form 483 issued December 19, 2019 · Wilson, North Carolina
- Inspection
- Dec 12 – Dec 19, 2019
- Investigator
- Libia M. Lugo
- Observations
- 1
- Pages
- 4
- FEI number
- 3002960808
In short: On December 19, 2019, FDA issued a Form 483 with 1 observation to Purdue Pharmaceuticals L.P. in Wilson, North Carolina (FEI 3002960808) after an inspection that ran Dec 12 – Dec 19, 2019. The investigator was Libia M. Lugo. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmPurdue Pharmaceuticals L.P. history
All 2 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 Purdue Pharmaceuticals L.P.?
FDA listed 1 observation on this Form 483, mostly about quality system. 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 Purdue Pharmaceuticals L.P.?
Libia M. Lugo is named on this Form 483, for the inspection of Dec 12 – Dec 19, 2019. Each investigator has a profile showing what they cite most.
When was Purdue Pharmaceuticals L.P. inspected by FDA?
The inspection ran Dec 12 – Dec 19, 2019, and the Form 483 is dated December 19, 2019.
How do I get the full Form 483 for Purdue Pharmaceuticals L.P.?
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.