FDA Inspection
UC San Diego Health Clinical Lab - HillcrestUC San Diego Health Clinical Lab - Hillcrest – FDA Inspection, Dec 31, 2012
Record Details
This FDA Inspection record concerns UC San Diego Health Clinical Lab - Hillcrest, with an inspection on December 31, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 31, 2012
- Product Type
- Biologics
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ID · f712bfde-ced4-4ea6-b68c-b2e6449641fc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 812462
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
5- 21 CFR 606.140(a)Establishment of spec., standards, and test procedures
- 21 CFR 600.14(a)(1)Who must report - receiving information
- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 211.25(a)GMP Training Frequency
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Other FDA inspections of UC San Diego Health Clinical Lab - Hillcrest
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 29, 2024 | Not classified | Los Angeles District Office | |
| July 26, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 8, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 20, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 8, 2011 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for UC San Diego Health Clinical Lab - Hillcrest
- FDA Inspection 1255961 - 2024-10-29
- FDA Inspection 1100244 - 2019-07-26
- FDA Inspection 1015624 - 2017-06-08
- FDA Inspection 943778 - 2015-08-20
- FDA Inspection 733782 - 2011-07-08
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