FDA Inspection 1219429 — Baptist Health IRB #1
The FDA completed an inspection of Baptist Health IRB #1 on Sep 28, 2023 in Montgomery, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 28, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Montgomery, AL (United States)
Additional details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |
| 7652 | 21 CFR 56.113 | Reporting |