854195

Exelead, Inc. — FEI 1000517970

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
November 7, 2013
Fiscal Year
2014
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Indianapolis, IN (United States)

Citations

IDCFRDescription
202821 CFR 211.192Extent of discrepancy, failure investigations
358521 CFR 211.110(a)Control procedures to monitor and validate performance