FDA Inspection
Providence Hospital Institutional Review BoardProvidence Hospital Institutional Review Board – FDA Inspection, Nov 3, 2009
Record Details
This FDA Inspection record concerns Providence Hospital Institutional Review Board, with an inspection on November 3, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 3, 2009
- Product Type
- Devices
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ID · 0986dfc6-4064-4f02-9222-ef1b1902ff28
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 626561
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.107(d)One non-affiliate member
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of Providence Hospital Institutional Review Board
1| Date | Classification | Office | Project area |
|---|---|---|---|
| November 20, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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