FDA Inspection
University of Virginia IRB for Health Sciences ResearchUniversity of Virginia IRB for Health Sciences Research – FDA Inspection, Apr 19, 2013
Record Details
This FDA Inspection record concerns University of Virginia IRB for Health Sciences Research, with an inspection on April 19, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- April 19, 2013
- Product Type
- Devices
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ID · b56446c9-d474-4c2d-a800-9f5dc0e1e2d2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 829777
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 50.20Circumstances of obtaining consent
- 21 CFR 56.109(e)IRB approvals/disapprovals - general
- 21 CFR 56.107(a)At least five members with varying backgrounds
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Other FDA inspections of University of Virginia IRB for Health Sciences Research
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2024 | NAI | Center for Biologics Evaluation and Research | Bioresearch Monitoring |
| April 26, 2018 | NAI | Bioresearch Monitoring | |
| May 4, 2010 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for University of Virginia IRB for Health Sciences Research
- FDA Inspection 1240614 - 2024-05-31
- FDA Inspection 1052472 - 2018-04-26
- FDA Inspection 660068 - 2010-05-04
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