906530

Alliance Packaging Group, Inc. — FEI 3003315832

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 4, 2014
Fiscal Year
2015
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Saukville, WI (United States)

Citations

IDCFRDescription
117721 CFR 211.63Equipment Design, Size and Location
354721 CFR 211.46(b)Equipment for Environmental Control
357221 CFR 211.100(b)Procedure Deviations Recorded and Justified
358521 CFR 211.110(a)Control procedures to monitor and validate performance
435321 CFR 211.160(b)(4)Instruments, apparatus, et. al. not meeting specs
439121 CFR 211.180(e)(2)Items to cover on annual reviews
440121 CFR 211.186(b)(9)Complete instructions, procedures, specifications et. al.