1197718
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 17, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Saint Louis, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 4304 | 21 CFR 211.68(b) | Written record not kept of program and validation data |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |