1219064
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 21, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Northridge, CA (United States)
Additional Details
Clinical Investigator (CI)
Citations
| ID | CFR | Description |
|---|---|---|
| 22727 | 21 CFR 312.64(b) | Safety Reports - Serious Events |
| 7498 | 21 CFR 312.66 | Unanticipated problems |
| 7562 | 21 CFR 312.60 | Informed consent |