FDA Inspection
William Beaumont Hospital IRBWilliam Beaumont Hospital IRB – FDA Inspection, Feb 19, 2016
Record Details
This FDA Inspection record concerns William Beaumont Hospital IRB, with an inspection on February 19, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 19, 2016
- Product Type
- Devices
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ID · 6de7b118-53fc-4a76-8502-bf97ac15f51d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 965949
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.113Reporting
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Other FDA inspections of William Beaumont Hospital IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 12, 2022 | NAI | Bioresearch Monitoring | |
| May 4, 2011 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 21, 2009 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for William Beaumont Hospital IRB
- FDA Inspection 1177820 - 2022-08-12
- FDA Inspection 722279 - 2011-05-04
- FDA Inspection 579892 - 2009-05-21
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