FDA Inspection
Purdue PharmaPurdue Pharma – FDA Inspection, Sep 13, 2013
Record Details
This FDA Inspection record concerns Purdue Pharma, with an inspection on September 13, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Purdue Pharma
- Inspection Date
- September 13, 2013
- Product Type
- Drugs
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ID · 2cd4bbf9-a993-4692-aa87-b42d35c7bb54
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 852516
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.100(a)Absence of Written Procedures
- 21 CFR 211.198(b)(1)Written complaint record must include
- 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 |
|---|---|---|---|
| April 26, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| 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 |
| July 15, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Purdue Pharma
- FDA Inspection 1087591 - 2019-04-26
- FDA Inspection 1025638 - 2017-08-04
- FDA Inspection 938743 - 2015-07-10
- FDA Inspection 734736 - 2011-07-15
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