FDA Inspection
Park Nicollet Institute IRBPark Nicollet Institute IRB – FDA Inspection, Mar 6, 2009
Record Details
This FDA Inspection record concerns Park Nicollet Institute IRB, with an inspection on March 6, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Park Nicollet Institute IRB
- Inspection Date
- March 6, 2009
- Product Type
- Devices
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ID · 73e824f5-1bb2-4b71-9dd8-0b3d95e6ff8d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 567031
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.111(c)Children as subjects
- 21 CFR 56.110(b)(2)Minor changes
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Other FDA inspections of Park Nicollet Institute IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 5, 2013 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Park Nicollet Institute IRB
- FDA Inspection 846772 - 2013-09-05
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