FDA Inspection
Marquette General Health System IRBMarquette General Health System IRB – FDA Inspection, Sep 20, 2012
Record Details
This FDA Inspection record concerns Marquette General Health System IRB, with an inspection on September 20, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 20, 2012
- Product Type
- Devices
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ID · f2e70091-1e97-4243-aeb8-c42a00d8953e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 800099
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of Marquette General Health System IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2025 | Not classified | Detroit District Office | |
| November 8, 2018 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 21, 2010 | OAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Marquette General Health System IRB
- FDA Inspection 1281270 - 2025-08-27
- FDA Inspection 1072655 - 2018-11-08
- FDA Inspection 697271 - 2010-10-21
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