1252285
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 15, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- San Francisco, CA (United States)
Additional Details
Sponsor-Investigator (S-I)
Citations
| ID | CFR | Description |
|---|---|---|
| 7505 | 21 CFR 312.55(a) | Investigator brochure |
| 7526 | 21 CFR 312.62(a) | Accountability records |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7552 | 21 CFR 312.66 | Changes in research |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |
| 7562 | 21 CFR 312.60 | Informed consent |
| 7632 | 21 CFR 312.6(a) | Required label statement |