FDA Inspection 1011589 — Northeast Alabama Regional Medical Center IRB
The FDA completed an inspection of Northeast Alabama Regional Medical Center IRB on April 27, 2017 in Anniston, AL. 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
- April 27, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Anniston, AL (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7276 | 21 CFR 56.107(c) | One scientific and one non-scientific member |
| 7290 | 21 CFR 56.108(c) | Members present for review |