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FDA Inspection
•Versiti Wisconsin, Inc•March 7, 2012

Versiti Wisconsin, Inc – FDA Inspection, Mar 7, 2012

Record Details

This FDA Inspection record concerns Versiti Wisconsin, Inc, with an inspection on March 7, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Versiti Wisconsin, Inc
Inspection Date
March 7, 2012
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 73299231-f424-4073-8d7e-c92950cc05d3

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
771740
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

3
  1. 21 CFR 1271.195(a)Adequate control, proper conditions
  2. 21 CFR 1271.47(a)Procedures for all other requirements
  3. 21 CFR 1271.160(b)(4)Training of personnel

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Versiti Wisconsin, Inc

5
DateClassificationOfficeProject area
May 31, 2018NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 22, 2016NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
March 21, 2014VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
November 2, 2010NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
January 22, 2009NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Versiti Wisconsin, Inc
  • FDA Inspection 1055648 - 2018-05-31
  • FDA Inspection 963086 - 2016-03-22
  • FDA Inspection 871901 - 2014-03-21
  • FDA Inspection 698180 - 2010-11-02
  • FDA Inspection 559314 - 2009-01-22

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