1166556

Illinois Tool Works Inc — FEI 3001238779

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 1, 2022
Fiscal Year
2022
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Olathe, KS (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
127021 CFR 211.68(b)input/output verification
136121 CFR 211.100(a)Absence of Written Procedures
154521 CFR 211.125(c)Label reconciliation discrepancies evaluation/investigation
188521 CFR 211.165(b)Microbiological testing
363221 CFR 211.170(b)Annual visual exams of drug products