FDA Inspection
University Of Michigan - IRBMEDUniversity Of Michigan - IRBMED – FDA Inspection, May 20, 2026
Record Details
This FDA Inspection record concerns University Of Michigan - IRBMED, with an inspection on May 20, 2026, issued by the Detroit District Office, covering biologics.
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ID · cc76a041-dbb6-4b13-99aa-5738c1a79ed2
Inspection Facts
- Inspection number
- 1317988
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 56.108(a)(1)Initial and continuing reviews
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.110(c)Method to keep members advised
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Other FDA inspections of University Of Michigan - IRBMED
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2022 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| July 27, 2018 | VAI | Center for Drug Evaluation and Research | Blood and Blood Products |
| June 17, 2014 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 12, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for University Of Michigan - IRBMED
- FDA Inspection 1178953 - 2022-09-02
- FDA Inspection 1061480 - 2018-07-27
- FDA Inspection 884319 - 2014-06-17
- FDA Inspection 635800 - 2009-11-12
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