FDA Inspection 824870 — Centra Health Inc IRB
The FDA completed an inspection of Centra Health Inc IRB on March 29, 2013 in Lynchburg, VA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 29, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Lynchburg, VA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7274 | 21 CFR 56.107(a) | At least five members with varying backgrounds |
| 7279 | 21 CFR 56.107(f) | Invited individual allowed to vote with IRB |
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7654 | 21 CFR 56.110(b) | Research not eligible for expedited review |