FDA Inspection 912294 — Alaska Regional Hospital IRB
The FDA completed an inspection of Alaska Regional Hospital IRB on January 28, 2015 in Anchorage, AK. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 28, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Anchorage, AK (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7371 | 21 CFR 56.108(a)(1) | Reporting findings and actions to investigator/institution |