FDA Inspection
Mark E. Polhemus, M.D., SUNY Upstate Medical UniversityMark E. Polhemus, M.D., SUNY Upstate Medical University – FDA Inspection, Jun 11, 2014
Record Details
This FDA Inspection record concerns Mark E. Polhemus, M.D., SUNY Upstate Medical University, with an inspection on June 11, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 11, 2014
- Product Type
- Biologics
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ID · 334965d5-c546-4d25-bb36-7d4f0598e1c9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 884978
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
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