FDA Inspection
Purdue Pharma L.P.Purdue Pharma L.P. – FDA Inspection, Dec 6, 2016
Record Details
This FDA Inspection record concerns Purdue Pharma L.P., with an inspection on December 6, 2016, issued by the New England District Office, covering human drugs.
- People
- Christopher Janik (FDA Associated Person)
- Dien N. Nguyen (Issuing Officer)
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ID · cdb4e580-db3e-4dc1-8537-5416abe48590
Inspection Facts
- Inspection number
- 994812
- FDA center
- Human Drugs
- Project area
- Postmarket Surv. and Epidemiology
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 314.80(b)Failure to develop written procedures
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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 |
| March 29, 2019 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| 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 1084657 - 2019-03-29
- FDA Inspection 979977 - 2016-07-28
- FDA Inspection 979095 - 2016-07-06
- FDA Inspection 783424 - 2012-05-25
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