FDA Inspection 729963 — University of California, Davis Med Center Blood Bank
The FDA completed an inspection of University of California, Davis Med Center Blood Bank on June 16, 2011 in Sacramento, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
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 |