FDA Inspection
Edward B. Portnoy, M.D.Edward B. Portnoy, M.D. – FDA Inspection, Dec 17, 2009
Record Details
This FDA Inspection record concerns Edward B. Portnoy, M.D., with an inspection on December 17, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Edward B. Portnoy, M.D.
- Inspection Date
- December 17, 2009
- Product Type
- Drugs
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ID · 9fb6023f-cc86-4686-819b-ee6f5f9e2a31
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 637141
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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