FDA Inspection
Versiti Wisconsin Inc. - Transfusion ServiceVersiti Wisconsin Inc. - Transfusion Service – FDA Inspection, Dec 17, 2009
Record Details
This FDA Inspection record concerns Versiti Wisconsin Inc. - Transfusion Service, with an inspection on December 17, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- December 17, 2009
- Product Type
- Biologics
View Company Profile
ID · 9e40d215-c73d-4f82-974b-49b7afa1c951
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 635815
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Provide proper equipment to meet requirements
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Versiti Wisconsin Inc. - Transfusion Service
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 27, 2022 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| April 5, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 17, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 13, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Versiti Wisconsin Inc. - Transfusion Service
- FDA Inspection 1280929 - 2025-08-20
- FDA Inspection 1174865 - 2022-06-27
- FDA Inspection 1054314 - 2018-04-05
- FDA Inspection 962743 - 2016-03-17
- FDA Inspection 870241 - 2014-03-13
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.