1254663
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 20, 2024
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Los Angeles, CA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7638 | 21 CFR 312.20(a) | Failure to submit an IND |