FDA Inspection 645193 — St. Vincent Evansville

St. Vincent Evansville — FEI 1870307

The FDA completed an inspection of St. Vincent Evansville on February 3, 2010 in Evansville, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 3, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Evansville, IN (United States)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
922521 CFR 606.171Biological product deviation report
9821 CFR 606.100(c)Thorough investigations