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1075476

Jurox Pty Ltd — FEI 3003483729

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
December 21, 2018
Fiscal Year
2019
Product Type
Veterinary
Project Area
Monitoring of Marketed Animal Drugs, Feed, and Devices
Location
Rutherford (Australia)

Facility

Other inspections at this facility

  • 1172980 (NAI Tue Jun 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945592 (VAI Fri Sep 25 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 755967 (VAI Fri Nov 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 700808 (OAI Thu Nov 11 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
121 CFR 11Electronic records
117421 CFR 211.42(b)Product flow through building is inadequate
127421 CFR 211.68(a)Calibration/Inspection/Checking not done
143421 CFR 211.42(c)(10)(iv)Environmental Monitoring System
191221 CFR 211.166(a)Written program not followed
192021 CFR 211.166(a)(3)Valid stability test methods
202721 CFR 211.192Investigations of discrepancies, failures
363221 CFR 211.170(b)Annual visual exams of drug products