FDA Inspection
Board of Regents University of Wisconsin SystemBoard of Regents University of Wisconsin System – FDA Inspection, Mar 28, 2012
Record Details
This FDA Inspection record concerns Board of Regents University of Wisconsin System, with an inspection on March 28, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 28, 2012
- Product Type
- Biologics
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ID · f3609588-fbc6-48ac-a8c2-abcf0cf23f41
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 775159
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 211.68(b)Written record not kept of program and validation data
- 21 CFR 606.160(b)Required records
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Other FDA inspections of Board of Regents University of Wisconsin System
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 30, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| November 5, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Board of Regents University of Wisconsin System
- FDA Inspection 853418 - 2013-10-30
- FDA Inspection 699034 - 2010-11-05
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