729963
University of California, Davis Med Center Blood Bank — FEI 2972222
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 16, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Sacramento, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |