FDA Inspection 806733 — Versiti Michigan, Inc

Versiti Michigan, Inc — FEI 1000517886

The FDA completed an inspection of Versiti Michigan, Inc on November 9, 2012 in Traverse City, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 9, 2012
Fiscal Year
2013
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Traverse City, MI (United States)

Citations

IDCFRDescription
20821 CFR 640.3(a)(1)Donor suitability procedures not followed