FDA Inspection 960542 — University Of Michigan Health West IRB

University Of Michigan Health West IRB — FEI 3002575745

The FDA completed an inspection of University Of Michigan Health West IRB on Jan 21, 2016 in Wyoming, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Jan 21, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Wyoming, MI (United States)

Additional Details

IRB

Citations

IDCFRDescription
731821 CFR 56.115(a)(2)Minutes of IRB meetings