FDA Inspection 997372 — Ascension St. John Hospital IRB

Ascension St. John Hospital IRB — FEI 1833142

The FDA completed an inspection of Ascension St. John Hospital IRB on Dec 23, 2016 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). 1 citation was issued during this inspection. Product area: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Dec 23, 2016
Fiscal Year
2017
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Grosse Pointe Woods, MI (United States)

Additional Details

IRB

Citations

IDCFRDescription
727821 CFR 56.107(e)Conflict of interest