FDA Inspection
Versiti Wisconsin, IncVersiti Wisconsin, Inc – FDA Inspection, Nov 18, 2013
Record Details
This FDA Inspection record concerns Versiti Wisconsin, Inc, with an inspection on November 18, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Versiti Wisconsin, Inc
- Inspection Date
- November 18, 2013
- Product Type
- Biologics
View Company Profile
ID · 59e7c561-0d25-4aae-9482-e277f2bdfe31
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 855783
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.100(b)Written SOPs available for use by personnel
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of Versiti Wisconsin, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2025 | Not classified | Minneapolis District Office | |
| December 13, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 23, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 15, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 5, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Versiti Wisconsin, Inc
- FDA Inspection 1275822 - 2025-06-12
- FDA Inspection 1194109 - 2022-12-13
- FDA Inspection 1066217 - 2018-08-23
- FDA Inspection 947280 - 2015-10-15
- FDA Inspection 761718 - 2012-01-05
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