FDA Inspection
Marquette General Health System IRBMarquette General Health System IRB – FDA Inspection, Oct 21, 2010
Record Details
This FDA Inspection record concerns Marquette General Health System IRB, with an inspection on October 21, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 21, 2010
- Product Type
- Devices
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ID · 9fd3ff0c-8798-47ba-9e28-c9efb7ad6bf7
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 697271
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
10- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.108(c)Members present for review
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.111(a)(5)Informed consent documented
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.110(b)Research not eligible for expedited review
- 21 CFR 56.110(b)(2)Minor changes
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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 |
| September 20, 2012 | VAI | 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 800099 - 2012-09-20
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