FDA Inspection 1238620 — University of California Irvine Medical Center Campus Donor Center
The FDA completed an inspection of University of California Irvine Medical Center Campus Donor Center on May 15, 2024 in Irvine, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 15, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Irvine, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 18093 | 21 CFR 630.10(g)(1) | Proof Of Identity |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |