FDA Inspection
Stephen G. Kaler, M.D.Stephen G. Kaler, M.D. – FDA Inspection, Jun 14, 2022
Record Details
This FDA Inspection record concerns Stephen G. Kaler, M.D., with an inspection on June 14, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Stephen G. Kaler, M.D.
- Inspection Date
- June 14, 2022
- Product Type
- Drugs
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ID · 46ef6444-07de-4ffe-8613-9365b5bc251e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1172314
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.103(a)IRB review requirement
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.56(a)Monitoring investigations
- 21 CFR 312.53(c)(1)Investigator statement (FDA 1572)
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.20Understandable language
- 21 CFR 50.20Circumstances of obtaining consent
- 21 CFR 50.25(a)(1)Procedures, identification of those which were experimental
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