FDA Inspection 829777 — University Of Virginia IRB For Health Sciences Research
The FDA completed an inspection of University Of Virginia IRB For Health Sciences Research on Apr 19, 2013 in Charlottesville, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Charlottesville, VA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7274 | 21 CFR 56.107(a) | At least five members with varying backgrounds |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7664 | 21 CFR 50.20 | Circumstances of obtaining consent |