FDA Inspection
Smitha Reddy, M.D.Smitha Reddy, M.D. – FDA Inspection, Aug 20, 2021
Record Details
This FDA Inspection record concerns Smitha Reddy, M.D., with an inspection on August 20, 2021, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Smitha Reddy, M.D.
- Inspection Date
- August 20, 2021
- Product Type
- Drugs
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ID · e28f926a-6443-4c30-8ebf-2f7fae402ce6
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1150615
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 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 312.62(a)Accountability records
- 21 CFR 50.20Consent not obtained, exceptions do not apply
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