906257

Bimeda MTC Animal Health Inc. — FEI 3001603179

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
November 21, 2014
Fiscal Year
2015
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Cambridge (Canada)

Citations

IDCFRDescription
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
135821 CFR 211.100(b)SOPs not followed / documented
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
143521 CFR 211.42(c)(10)(v)Cleaning System
193321 CFR 211.167(a)Sterility/pyrogens - test methods written, followed
240621 CFR 211.194(a)(8)Identification of Person Performing Review of Lab Records
441221 CFR 211.194(a)(7)Signatures and dates--person who performs test