FDA Inspection
Gelernt, Mark D., MDGelernt, Mark D., MD – FDA Inspection, May 20, 2015
Record Details
This FDA Inspection record concerns Gelernt, Mark D., MD, with an inspection on May 20, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Gelernt, Mark D., MD
- Inspection Date
- May 20, 2015
- Product Type
- Drugs
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ID · 22e9e6f6-4cd7-4a9b-9a53-054774f1f74b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 925860
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
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