FDA Inspection 603192 — UCLA Health, Component Processing Laboratory, Hematologic Malignancies/Stem Cell Transplantation Program
The FDA completed an inspection of UCLA Health, Component Processing Laboratory, Hematologic Malignancies/Stem Cell Transplantation Program on August 12, 2009 in Los Angeles, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 12, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 98 | 21 CFR 606.100(c) | Thorough investigations |