FDA Inspection
Purdue PharmaPurdue Pharma – FDA Inspection, Apr 26, 2019
Record Details
This FDA Inspection record concerns Purdue Pharma, with an inspection on April 26, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · e8217f26-6c57-472f-82cb-55f276da838b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1087591
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Purdue Pharma
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 10, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 13, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 15, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Purdue Pharma
- FDA Inspection 1025638 - 2017-08-04
- FDA Inspection 938743 - 2015-07-10
- FDA Inspection 852516 - 2013-09-13
- FDA Inspection 734736 - 2011-07-15
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