658608

Pace Analytical Life Sciences — FEI 3006500621

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 23, 2010
Fiscal Year
2010
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Salem, NH (United States)

Citations

IDCFRDescription
180921 CFR 211.160(a)Following/documenting laboratory controls
191221 CFR 211.166(a)Written program not followed
203221 CFR 211.194(b)Test method modification records not maintained
203521 CFR 211.194(e)Stability testing records not included
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action