FDA Inspection 812462 — UC San Diego Health Clinical Lab - Hillcrest
The FDA completed an inspection of UC San Diego Health Clinical Lab - Hillcrest on December 31, 2012 in San Diego, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 31, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- San Diego, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 77 | 21 CFR 606.100(b) | Written SOPs available for use by personnel |
| 9087 | 21 CFR 600.14(a)(1) | Who must report - receiving information |
| 98 | 21 CFR 606.100(c) | Thorough investigations |