FDA Inspection
U Of MN Research Subjects' Protection Program/ IRBU Of MN Research Subjects' Protection Program/ IRB – FDA Inspection, Sep 25, 2015
Record Details
This FDA Inspection record concerns U Of MN Research Subjects' Protection Program/ IRB, with an inspection on September 25, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 25, 2015
- Product Type
- Drugs
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ID · 8936f59f-63d4-40cb-98d1-f0f643facf75
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945720
- FDA center
- Human Drugs
- 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 | |
| October 18, 2011 | VAI | Center for Devices and Radiological Health | 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 749422 - 2011-10-18
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