FDA Inspection
Allina Health [IRB]Allina Health [IRB] – FDA Inspection, Jul 1, 2013
Record Details
This FDA Inspection record concerns Allina Health [IRB], with an inspection on July 1, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Allina Health [IRB]
- Inspection Date
- July 1, 2013
- Product Type
- Devices
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ID · be8e01d2-459d-4395-9a0e-ebc06884fe33
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 838055
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
4- 21 CFR 56.104(c)Emergency use and IRB approval
- 21 CFR 56.115(b)Retention of records
- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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Other FDA inspections of Allina Health [IRB]
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 12, 2025 | NAI | Bioresearch Monitoring | |
| July 20, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 26, 2010 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| March 30, 2009 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Allina Health [IRB]
- FDA Inspection 1296634 - 2025-12-12
- FDA Inspection 1029702 - 2017-07-20
- FDA Inspection 665580 - 2010-05-26
- FDA Inspection 572661 - 2009-03-30
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