FDA Inspection
Pierre Fabre Pharmaceuticals, Inc.Pierre Fabre Pharmaceuticals, Inc. – FDA Inspection, Nov 1, 2024
Record Details
This FDA Inspection record concerns Pierre Fabre Pharmaceuticals, Inc., with an inspection on November 1, 2024, issued by the New Jersey District Office, covering human drugs.
- Person
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ID · 01cb2931-62ce-4bde-84b6-ab813b5e54a6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1253273
- FDA center
- Human Drugs
- Project area
- Postmarketing Surveillance and Epidemiology: Human Drugs
FDA Citations
2- 21 CFR 314.80(f)(4)Incomplete initial reporter information on ICSR
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
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Other FDA inspections of Pierre Fabre Pharmaceuticals, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 27, 2022 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| December 30, 2015 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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