FDA Inspection
Wayne Memorial Hospital IRBWayne Memorial Hospital IRB – FDA Inspection, Feb 14, 2013
Record Details
This FDA Inspection record concerns Wayne Memorial Hospital IRB, with an inspection on February 14, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Wayne Memorial Hospital IRB
- Inspection Date
- February 14, 2013
- Product Type
- Drugs
View Company Profile
ID · eff9f896-3344-4fff-a6f5-4de61d45fe38
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 820754
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(4)Copies of IRB/CI correspondence
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(3)Records of continuing review
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