1215162
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 17, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Gainesville, GA (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7333 | 21 CFR 56.104(c) | Emergency use and IRB approval |
| 7552 | 21 CFR 312.66 | Changes in research |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |
| 7629 | 21 CFR 312.56(c) | Annual report |