FDA Inspection
George C. Velmahos, M.D., Ph.DGeorge C. Velmahos, M.D., Ph.D – FDA Inspection, Jul 25, 2013
Record Details
This FDA Inspection record concerns George C. Velmahos, M.D., Ph.D, with an inspection on July 25, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 25, 2013
- Product Type
- Biologics
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ID · e90a68e2-6537-4198-ae7c-bbaaf31ffb70
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 842069
- FDA center
- Biologics
- 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 50.27(a)Consent form not approved/signed/dated
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