FDA Inspection
St Mark's Hospital Institutional Review BoardSt Mark's Hospital Institutional Review Board – FDA Inspection, Mar 7, 2014
Record Details
This FDA Inspection record concerns St Mark's Hospital Institutional Review Board, with an inspection on March 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 7, 2014
- Product Type
- Devices
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ID · 962d337c-053f-4c74-9a36-29700246dcac
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 885854
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.109(f)Continuing review
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Other FDA inspections of St Mark's Hospital Institutional Review Board
1| Date | Classification | Office | Project area |
|---|---|---|---|
| October 27, 2008 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
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