FDA Inspection
University of California, Davis Med Center Blood BankUniversity of California, Davis Med Center Blood Bank – FDA Inspection, Jun 16, 2011
Record Details
This FDA Inspection record concerns University of California, Davis Med Center Blood Bank, with an inspection on June 16, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 16, 2011
- Product Type
- Biologics
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ID · efe8460d-b21b-41ea-b681-a7fa545dedc6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 729963
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of University of California, Davis Med Center Blood Bank
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 17, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 7, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 4, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 12, 2012 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for University of California, Davis Med Center Blood Bank
- FDA Inspection 1235457 - 2024-03-21
- FDA Inspection 1087630 - 2019-04-17
- FDA Inspection 1027895 - 2017-09-07
- FDA Inspection 907137 - 2014-12-04
- FDA Inspection 810452 - 2012-12-12
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