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FDA Inspection 1054495 — Ortho-Clinical Diagnostics, Inc.

Ortho-Clinical Diagnostics, Inc. — FEI 2250051

The FDA completed an inspection of Ortho-Clinical Diagnostics, Inc. on April 18, 2018 in Raritan, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
April 18, 2018
Fiscal Year
2018
Product Type
Biologics
Project Area
Blood and Blood Products
Location
Raritan, NJ (United States)

Facility

Other inspections at this facility

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  • 1192367 (NAI Fri Dec 09 2022 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))

FDA data resources