FDA Inspection
University Of Michigan - IRBMEDUniversity Of Michigan - IRBMED – FDA Inspection, Jul 27, 2018
Record Details
This FDA Inspection record concerns University Of Michigan - IRBMED, with an inspection on July 27, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Andrace Deyampert (FDA Associated Person)
- Sherri J. Jackson (Issuing Officer)
View Company Profile
ID · e4402903-4cbf-42c3-9e74-9bdc49daefe0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1061480
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
- 21 CFR 56.108(b)(1)Prompt reporting of unanticipated problems
- 21 CFR 56.113Reporting
Full citation text and observation details available on the Dashboard.
Other FDA inspections of University Of Michigan - IRBMED
4| Date | Classification | Office | Project area |
|---|---|---|---|
| May 20, 2026 | Not classified | Detroit District Office | Project Evaluation: Devices |
| September 2, 2022 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| 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 1317988 - 2026-05-20
- FDA Inspection 1178953 - 2022-09-02
- FDA Inspection 884319 - 2014-06-17
- FDA Inspection 635800 - 2009-11-12
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.