921147

Weeks & Leo Co Inc — FEI 1910338

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 10, 2015
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Clive, IA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
121321 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
202721 CFR 211.192Investigations of discrepancies, failures
358521 CFR 211.110(a)Control procedures to monitor and validate performance
437221 CFR 211.188(b)(8)Labeling control records including specimens or copies