FDA Inspection 836906 — Alamance Regional Medical Center IRB
The FDA completed an inspection of Alamance Regional Medical Center IRB on June 20, 2013 in Burlington, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 20, 2013
- Fiscal Year
- 2013
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Burlington, NC (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7293 | 21 CFR 56.109(f) | Continuing review |
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7370 | 21 CFR 56.111(c) | Children as subjects |