810555

Vortech Pharmaceuticals Ltd — FEI 1810390

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 14, 2012
Fiscal Year
2013
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Dearborn, MI (United States)

Citations

IDCFRDescription
113321 CFR 211.25(a)GMP Training Frequency
144821 CFR 211.111Establishment of time limitations
192621 CFR 211.166(b)Adequate number of batches on stability
360321 CFR 211.160(b)Scientifically sound laboratory controls
363221 CFR 211.170(b)Annual visual exams of drug products
431421 CFR 211.84(d)(2)Reports of Analysis (Components)