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FDA Inspection 1094948 — FUJIFILM Healthcare Americas Corporation

FUJIFILM Healthcare Americas Corporation — FEI 2431293

The FDA completed an inspection of FUJIFILM Healthcare Americas Corporation on July 2, 2019 in Wayne, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
July 2, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Wayne, NJ (United States)

Citations

IDCFRDescription
337521 CFR 820.198(e)Records of complaint investigation

Facility

Other inspections at this facility

  • 922868 (OAI Thu Apr 09 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 864022 (VAI Thu Jan 16 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 706457 (VAI Mon Dec 13 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources