FDA Inspection 749422 — University of Minnesota IRB

University of Minnesota IRB — FEI 2127205

The FDA completed an inspection of University of Minnesota IRB on October 18, 2011 in Minneapolis, MN. 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: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 18, 2011
Fiscal Year
2012
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Minneapolis, MN (United States)

Additional Details

IRB

Citations

IDCFRDescription
728121 CFR 56.108(a)(1)Initial and continuing reviews