FDA Inspection 796549 — Swedish Covenant Hospital IRB

Swedish Covenant Hospital IRB — FEI 1473008

The FDA completed an inspection of Swedish Covenant Hospital IRB on Sep 11, 2012 in Chicago, IL. 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). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Sep 11, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Chicago, IL (United States)

Additional Details

IRB

Citations

IDCFRDescription
728121 CFR 56.108(a)(1)Initial and continuing reviews
731821 CFR 56.115(a)(2)Minutes of IRB meetings