787706

Illinois Tool Works Inc — FEI 3001238779

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 30, 2012
Fiscal Year
2012
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
135821 CFR 211.100(b)SOPs not followed / documented
197621 CFR 211.182Specific information required in individual logs
197821 CFR 211.182Personnel dating/signing equipment log
199921 CFR 211.184(a)Record information required
200821 CFR 211.186(a)Written procedures followed
200921 CFR 211.188Prepared for each batch, include complete information
202621 CFR 211.192Quality control unit review of records
439121 CFR 211.180(e)(2)Items to cover on annual reviews