FDA Inspection
Inova Institutional Review Board (IRB)Inova Institutional Review Board (IRB) – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Inova Institutional Review Board (IRB), with an inspection on December 21, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f57d3806-235d-4866-b6ea-38ea0b55b42a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1075242
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 56.115(a)(5)List of members
- 21 CFR 56.115(a)(2)Minutes of IRB meetings
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Other FDA inspections of Inova Institutional Review Board (IRB)
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 16, 2023 | NAI | Bioresearch Monitoring | |
| October 30, 2013 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 3, 2008 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Inova Institutional Review Board (IRB)
- FDA Inspection 1223654 - 2023-11-16
- FDA Inspection 900995 - 2013-10-30
- FDA Inspection 548268 - 2008-11-03
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