904540

Piramal Critical Care, Inc. — FEI 1000135935

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 31, 2014
Fiscal Year
2015
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Bethlehem, PA (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
127021 CFR 211.68(b)input/output verification
139521 CFR 211.103Actual vs. theoretical yields not determined
202721 CFR 211.192Investigations of discrepancies, failures
360321 CFR 211.160(b)Scientifically sound laboratory controls
440221 CFR 211.192Written record of investigation incomplete