FDA Inspection
Paul D. Mintz, M.D.Paul D. Mintz, M.D. – FDA Inspection, Mar 28, 2014
Record Details
This FDA Inspection record concerns Paul D. Mintz, M.D., with an inspection on March 28, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Paul D. Mintz, M.D.
- Inspection Date
- March 28, 2014
- Product Type
- Biologics
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ID · 3eb915b7-c20c-4d2c-b2bd-d2cb55ff38d6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871389
- FDA center
- Biologics
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 812.100Investigator non-compliance with agreement/plan/regulations
- 21 CFR 812.36(e)No IRB approval for treatment use
- 21 CFR 812.100Investigator lack of control of investigational devices
- 21 CFR 812.100No investigator protection - subject rights, safety, welfare
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