FDA Inspection
St. Anthony Hospital IRBSt. Anthony Hospital IRB – FDA Inspection, Apr 14, 2009
Record Details
This FDA Inspection record concerns St. Anthony Hospital IRB, with an inspection on April 14, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- St. Anthony Hospital IRB
- Inspection Date
- April 14, 2009
- Product Type
- Devices
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ID · 83575305-2398-4697-92ea-ba5d7a6aaee9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 589557
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(6)Written procedures per 56.108(a) and (b)
- 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
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Other FDA inspections of St. Anthony Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 21, 2016 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for St. Anthony Hospital IRB
- FDA Inspection 968315 - 2016-01-21
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