FDA Inspection
Jaime R. MerchanFDA Inspection 723787 - Jaime R. Merchan - April 20, 2011
Record Details
This FDA Inspection record concerns Jaime R. Merchan, with an inspection on April 20, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Jaime R. Merchan
- Inspection Date
- April 20, 2011
- Product Type
- Drugs
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ID · 51b45e24-cecc-4140-a455-122b80e6d68e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 723787
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 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 Jaime R. Merchan
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 5, 2012 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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