FDA Inspection
George Burke, III, M.D.George Burke, III, M.D. – FDA Inspection, Aug 10, 2015
Record Details
This FDA Inspection record concerns George Burke, III, M.D., with an inspection on August 10, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- George Burke, III, M.D.
- Inspection Date
- August 10, 2015
- Product Type
- Drugs
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ID · e0accf71-a7e1-444a-a43c-9fcd3db38428
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938109
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.50General responsibilities of sponsors
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.20Understandable language
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