FDA Inspection
Ganesh Kambhampati, M.D.Ganesh Kambhampati, M.D. – FDA Inspection, Nov 28, 2018
Record Details
This FDA Inspection record concerns Ganesh Kambhampati, M.D., with an inspection on November 28, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- Person
- Sandra S. Saniga (Issuing Officer)
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ID · 56809541-0d36-4709-8fa7-ebcc1bf4c077
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1073913
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 312.66Unanticipated problems
- 21 CFR 50.20Circumstances of obtaining consent
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