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1192367

Ortho-Clinical Diagnostics, Inc. — FEI 2250051

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
December 9, 2022
Fiscal Year
2023
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Raritan, NJ (United States)

Facility

Other inspections at this facility

  • 1264865 (NAI Fri Jun 13 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1054495 (VAI Wed Apr 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1002540 (VAI Thu Jul 28 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 918943 (NAI Mon Mar 16 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 805989 (VAI Fri Oct 26 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
235021 CFR 820.25(b)Training - Lack of or inadequate procedures
312721 CFR 820.80(e)Documentation
313021 CFR 820.100(a)Lack of or inadequate procedures
908921 CFR 600.14(c)When to report