FDA Inspection
Purdue Pharma L.P.Purdue Pharma L.P. – FDA Inspection, Oct 5, 2023
Record Details
This FDA Inspection record concerns Purdue Pharma L.P., with an inspection on October 5, 2023, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 817234d2-cd59-4948-a2ce-9a2fd906ed9e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1219674
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR
- 21 CFR 314.80(b)Failure to develop written procedures
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Failure to report non-alert ADEs
- 21 CFR 314.80(c)(2)(ii)(B)Late submission of an ICSR
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Other FDA inspections of Purdue Pharma L.P.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 29, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 6, 2016 | Not classified | New England District Office | Postmarket Surv. and Epidemiology |
| July 28, 2016 | NAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
| July 6, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 25, 2012 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Purdue Pharma L.P.
- FDA Inspection 1084657 - 2019-03-29
- FDA Inspection 994812 - 2016-12-06
- FDA Inspection 979977 - 2016-07-28
- FDA Inspection 979095 - 2016-07-06
- FDA Inspection 783424 - 2012-05-25
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