FDA Inspection
Pierre Fabre Pharmaceuticals, Inc.Pierre Fabre Pharmaceuticals, Inc. – FDA Inspection, Jul 27, 2022
Record Details
This FDA Inspection record concerns Pierre Fabre Pharmaceuticals, Inc., with an inspection on July 27, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 27, 2022
- Product Type
- Drugs
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ID · 5e316c74-1c4a-4b0e-8a3f-5c9b20cfd3fd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1175515
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 314.80(c)(1)(ii)Failure to investigate serious, unexpected events
- 21 CFR 314.81(b)(2)Timely submission
- 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(f)(4)Incomplete initial reporter information on ICSR
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Other FDA inspections of Pierre Fabre Pharmaceuticals, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2024 | VAI | New Jersey District Office | Postmarketing Surveillance and Epidemiology: Human Drugs |
| December 30, 2015 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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