1283668
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 24, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rye, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9078 | 21 CFR 600.12(a) | Maintenance - tracing |