FDA Inspection
Inova Institutional Review Board (IRB)Inova Institutional Review Board (IRB) – FDA Inspection, Oct 30, 2013
Record Details
This FDA Inspection record concerns Inova Institutional Review Board (IRB), with an inspection on October 30, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 30, 2013
- Product Type
- Devices
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ID · 570326a1-bf2a-4c22-8808-50fd17cc4744
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 900995
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
2- 21 CFR 56.111(a)(4)Informed consent sought
- 21 CFR 56.108(a)(1)Initial and continuing reviews
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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 | |
| December 21, 2018 | 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 1075242 - 2018-12-21
- FDA Inspection 548268 - 2008-11-03
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