1211280
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 2, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Pembroke Pines, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22728 | 21 CFR 312.64(b) | Safety Reports - Non-Serious Events |
| 7530 | 21 CFR 312.62(b) | Case history records- inadequate or inadequate |
| 7560 | 21 CFR 312.60 | FD-1572, protocol compliance |