FDA Inspection 1099006 — St. Josephs / Candler Health System IRB
The FDA completed an inspection of St. Josephs / Candler Health System IRB on August 7, 2019 in Savannah, GA. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 7, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Savannah, GA (United States)
Additional Details
IRB
Citations
| ID | CFR | Description |
|---|---|---|
| 7281 | 21 CFR 56.108(a)(1) | Initial and continuing reviews |
| 7320 | 21 CFR 56.109(e) | IRB approvals/disapprovals - general |