FDA Inspection
The Waterbury Hospital Institutional Review BoardThe Waterbury Hospital Institutional Review Board – FDA Inspection, Sep 17, 2012
Record Details
This FDA Inspection record concerns The Waterbury Hospital Institutional Review Board, with an inspection on September 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 17, 2012
- Product Type
- Devices
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ID · 1a0017cf-84a4-4cf3-bb47-15bd35e0e084
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 799726
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(e)Conflict of interest
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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