FDA Inspection
Monongalia General Hospital IRBMonongalia General Hospital IRB – FDA Inspection, Jan 13, 2012
Record Details
This FDA Inspection record concerns Monongalia General Hospital IRB, with an inspection on January 13, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- January 13, 2012
- Product Type
- Devices
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ID · ac7f84a2-fc4d-43d7-b634-3241c2741dde
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 763556
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
8- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(1)Copies of all research proposals and related documents
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
- 21 CFR 56.115(a)(3)Records of continuing review
- 21 CFR 56.108(a)(2)More frequent reviews, verification of no changes
- 21 CFR 56.108(a)(4)Changes in approved research
- 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
- 21 CFR 56.108(b)(2)Prompt reporting of noncompliance
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Other FDA inspections of Monongalia General Hospital IRB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 4, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Monongalia General Hospital IRB
- FDA Inspection 916675 - 2015-03-04
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