FDA Inspection 765463 — Wayne State University Institutional Review Board

Wayne State University Institutional Review Board — FEI 1824616

The FDA completed an inspection of Wayne State University Institutional Review Board on January 26, 2012 in Detroit, 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: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
January 26, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Detroit, MI (United States)

Additional Details

IRB

Citations

IDCFRDescription
730521 CFR 56.110(b)(2)Minor changes