FDA Inspection 776083 — Ascension St. John Hospital IRB

Ascension St. John Hospital IRB — FEI 1833142

The FDA completed an inspection of Ascension St. John Hospital IRB on Mar 21, 2012 in Grosse Pointe Woods, 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). 2 citations were issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Mar 21, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Grosse Pointe Woods, MI (United States)

Additional Details

IRB

Citations

IDCFRDescription
291621 CFR 812.7(d)Investigational device represented as safe and /or effective
728621 CFR 56.108(b)(1)Prompt reporting of unanticipated problems