FDA Inspection
Purdue Pharma L.P.Purdue Pharma L.P. – FDA Inspection, Mar 29, 2019
Record Details
This FDA Inspection record concerns Purdue Pharma L.P., with an inspection on March 29, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 5c8a08a9-c10a-4fc6-875d-a0744f103817
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1084657
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Purdue Pharma L.P.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2023 | 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 1219674 - 2023-10-05
- 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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