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1063744

Janssen Ortho LLC — FEI 3002942061

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
August 28, 2018
Fiscal Year
2018
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Gurabo, PR (United States)

Facility

Other inspections at this facility

  • 1200973 (VAI Tue Mar 28 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1012089 (VAI Fri May 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 930456 (VAI Fri May 29 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 819622 (VAI Fri Feb 22 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 729698 (VAI Mon Jun 13 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
358521 CFR 211.110(a)Control procedures to monitor and validate performance
360321 CFR 211.160(b)Scientifically sound laboratory controls
436821 CFR 211.188(b)(12)Investigations made into any unexplained discrepancy