FDA Inspection 791741 — Northeast Alabama Regional Medical Center IRB
The FDA completed an inspection of Northeast Alabama Regional Medical Center IRB on July 20, 2012 in Anniston, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 20, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Anniston, AL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7286 | 21 CFR 56.108(b)(1) | Prompt reporting of unanticipated problems |
| 7290 | 21 CFR 56.108(c) | Members present for review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7368 | 21 CFR 56.108(a)(2) | More frequent reviews, verification of no changes |