FDA Inspection 1117830 — Indiana University IRB

Indiana University IRB — FEI 1823570

The FDA completed an inspection of Indiana University IRB on Feb 14, 2020 in Indianapolis, IN. 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: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI)
End Date
Feb 14, 2020
Fiscal Year
2020
Product Type
Biologics
Project Area
Bioresearch Monitoring
Location
Indianapolis, IN (United States)

Additional Details

IRB

Citations

IDCFRDescription
732121 CFR 56.110(c)Method to keep members advised

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