FDA Inspection 1217721 — Baton Rouge General Medical Center IRB
The FDA completed an inspection of Baton Rouge General Medical Center IRB on September 14, 2023 in Baton Rouge, LA. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 14, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Bioresearch Monitoring
- Location
- Baton Rouge, LA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7318 | 21 CFR 56.115(a)(2) | Minutes of IRB meetings |
| 7342 | 21 CFR 56.108(b)(2) | Prompt reporting of noncompliance |
| 7353 | 21 CFR 50.52 | Factors required for approval |