FDA Inspection 954469 — Indiana Organ Procurement Organization

Indiana Organ Procurement Organization — FEI 3003103596

The FDA completed an inspection of Indiana Organ Procurement Organization on December 11, 2015 in Indianapolis, IN. 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: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 11, 2015
Fiscal Year
2016
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Indianapolis, IN (United States)

Citations

IDCFRDescription
1237321 CFR 1271.200(d)Inspected routinely