900536

Vortech Pharmaceuticals Ltd — FEI 1810390

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
October 22, 2014
Fiscal Year
2015
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Dearborn, MI (United States)

Citations

IDCFRDescription
110521 CFR 211.22(d)Procedures not in writing, fully followed
360321 CFR 211.160(b)Scientifically sound laboratory controls
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
440621 CFR 211.194(a)(2)Suitability of testing methods verified