FDA Inspection
Wayne State University Institutional Review BoardWayne State University Institutional Review Board – FDA Inspection, Feb 2, 2010
Record Details
This FDA Inspection record concerns Wayne State University Institutional Review Board, with an inspection on February 2, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 2, 2010
- Product Type
- Devices
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ID · bb1fb274-cce1-4393-985d-ebf7afc0ab5e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 645453
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 56.115(a)(5)List of members
- 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 56.107(f)Invited individual allowed to vote with IRB
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Other FDA inspections of Wayne State University Institutional Review Board
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 1, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 12, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| January 26, 2012 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Wayne State University Institutional Review Board
- FDA Inspection 1118237 - 2019-11-01
- FDA Inspection 1023236 - 2017-05-12
- FDA Inspection 765463 - 2012-01-26
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