Purdue Pharmaceuticals L.P.
Form 483 issued August 11, 2022 · Wilson, North Carolina
- Inspection
- Jul 26 – Aug 11, 2022
- Investigator
- Pratik S. Upadhyay
- Observations
- 8
- Pages
- 16
- FEI number
- 3002960808
In short: On August 11, 2022, FDA issued a Form 483 with 8 observations to Purdue Pharmaceuticals L.P. in Wilson, North Carolina (FEI 3002960808) after an inspection that ran Jul 26 – Aug 11, 2022. The investigator was Pratik S. Upadhyay. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The written record or copy of the record of an investigation of a complaint conducted in…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 0421 CFR 211.68(b)21 CFR 11
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 211.198(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Purdue Pharmaceuticals L.P.?
FDA listed 8 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Purdue Pharmaceuticals L.P.?
Pratik S. Upadhyay is named on this Form 483, for the inspection of Jul 26 – Aug 11, 2022. Each investigator has a profile showing what they cite most.
When was Purdue Pharmaceuticals L.P. inspected by FDA?
The inspection ran Jul 26 – Aug 11, 2022, and the Form 483 is dated August 11, 2022.
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.