956003
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 19, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hazelwood, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 300 | 21 CFR 640.67 | Laboratory tests |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |