FDA Inspection
Janet K. GerstenJanet K. Gersten – FDA Inspection, Jan 14, 2014
Record Details
This FDA Inspection record concerns Janet K. Gersten, with an inspection on January 14, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Janet K. Gersten
- Inspection Date
- January 14, 2014
- Product Type
- Drugs
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ID · 9f03c4ff-5600-4447-9f82-7f792df9476b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 862286
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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Other FDA inspections of Janet K. Gersten
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 22, 2025 | NAI | Bioresearch Monitoring | |
| October 24, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Janet K. Gersten
- FDA Inspection 1297276 - 2025-12-22
- FDA Inspection 804634 - 2012-10-24
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