FDA Inspection 1089015 — Bellin Health System Inc., IRB

Bellin Health System Inc., IRB — FEI 3009198310

The FDA completed an inspection of Bellin Health System Inc., IRB on May 9, 2019 in Green Bay, WI. 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: Drugs.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
May 9, 2019
Fiscal Year
2019
Product Type
Drugs
Project Area
Bioresearch Monitoring
Location
Green Bay, WI (United States)

Additional Details

IRB

Citations

IDCFRDescription
729321 CFR 56.109(f)Continuing review