FDA Inspection
Mercedes SamsonMercedes Samson – FDA Inspection, Nov 2, 2018
Record Details
This FDA Inspection record concerns Mercedes Samson, with an inspection on November 2, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · b4b30615-194e-4c74-89c1-c7746bf24c9a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1070905
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.62(a)Accountability records
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Other FDA inspections of Mercedes Samson
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 17, 2017 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Mercedes Samson
- FDA Inspection 1025884 - 2017-08-17
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