FDA Inspection
U Of MN Research Subjects' Protection Program/ IRBU Of MN Research Subjects' Protection Program/ IRB – FDA Inspection, Oct 18, 2011
Record Details
This FDA Inspection record concerns U Of MN Research Subjects' Protection Program/ IRB, with an inspection on October 18, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 18, 2011
- Product Type
- Devices
View Company Profile
ID · b8a9992a-4978-43a8-86e7-7c0d9be87645
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749422
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 56.108(a)(1)Initial and continuing reviews
Full citation text and observation details available on the Dashboard.
Other FDA inspections of U Of MN Research Subjects' Protection Program/ IRB
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 28, 2025 | NAI | Bioresearch Monitoring | |
| December 12, 2019 | NAI | Bioresearch Monitoring | |
| September 25, 2015 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for U Of MN Research Subjects' Protection Program/ IRB
- FDA Inspection 1272387 - 2025-05-28
- FDA Inspection 1115377 - 2019-12-12
- FDA Inspection 945720 - 2015-09-25
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.