FDA Inspection
Amit n.m.i. Sharma, M.D. and Arnold L. Silva, M.D., Ph.DAmit n.m.i. Sharma, M.D. and Arnold L. Silva, M.D., Ph.D – FDA Inspection, Aug 20, 2012
Record Details
This FDA Inspection record concerns Amit n.m.i. Sharma, M.D. and Arnold L. Silva, M.D., Ph.D, with an inspection on August 20, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 20, 2012
- Product Type
- Drugs
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ID · 30260aa0-cb48-48a8-a9de-e6b43a6abf19
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 794663
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.64(b)Safety reports
- 21 CFR 50.27(a)Consent form not approved/signed/dated
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