FDA Inspection
Sudesh Nagavalli, M.D.Sudesh Nagavalli, M.D. – FDA Inspection, Dec 13, 2012
Record Details
This FDA Inspection record concerns Sudesh Nagavalli, M.D., with an inspection on December 13, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Sudesh Nagavalli, M.D.
- Inspection Date
- December 13, 2012
- Product Type
- Biologics
View Company Profile
ID · 8c37edff-37e7-4192-bf28-5d53b29d6e0a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 814629
- FDA center
- Biologics
- 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 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.62(a)Accountability records
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