FDA Inspection
Versiti Wisconsin, IncVersiti Wisconsin, Inc – FDA Inspection, Mar 21, 2014
Record Details
This FDA Inspection record concerns Versiti Wisconsin, Inc, with an inspection on March 21, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- Versiti Wisconsin, Inc
- Inspection Date
- March 21, 2014
- Product Type
- Biologics
View Company Profile
ID · 253ca5e8-1487-4d50-9557-3cfb1eee4b34
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 871901
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.170(b)Qualifications lacking
- 21 CFR 1271.200(b)Procedures inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Versiti Wisconsin, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 31, 2018 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 22, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 7, 2012 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| November 2, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 22, 2009 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Versiti Wisconsin, Inc
- FDA Inspection 1055648 - 2018-05-31
- FDA Inspection 963086 - 2016-03-22
- FDA Inspection 771740 - 2012-03-07
- FDA Inspection 698180 - 2010-11-02
- FDA Inspection 559314 - 2009-01-22
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.