1013016

Packaging Group Corp — FEI 3010838254

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 6, 2017
Fiscal Year
2017
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Michigan City, IN (United States)

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
136121 CFR 211.100(a)Absence of Written Procedures
163221 CFR 211.130(c)Lot or control number assigned
197521 CFR 211.182Written records kept in individual logs
201221 CFR 211.188(b)Batch production and Batch Control Record Requirements
202721 CFR 211.192Investigations of discrepancies, failures
430621 CFR 211.80(a)Written Procedures Not Followed