FDA Inspection
McLean Hospital Institutional Review BoardMcLean Hospital Institutional Review Board – FDA Inspection, May 9, 2013
Record Details
This FDA Inspection record concerns McLean Hospital Institutional Review Board, with an inspection on May 9, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- May 9, 2013
- Product Type
- Drugs
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ID · fa60a63d-905e-4282-bb19-f7b9ab681753
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 828662
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
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