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FUJIFILM Healthcare Americas Corporation — FDA Facility Profile

FEI 2431293

FUJIFILM Healthcare Americas Corporation is an FDA-registered facility (FEI 2431293) located in Wayne, NJ, US. RegDataLab tracks 4 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
Wayne, NJ (US)
Registration Expires
N/A
Operations
Source
inspections

Recent inspections

  • 1094948 (VAI Tue Jul 02 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 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))

Compliance actions

Import refusals

  • 799-1006137-3/21/1 (Wed Oct 12 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8849490-1/11/1 (Mon May 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-8243218-7/11/1 (Fri Sep 04 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 799-1037326-9/1/1 (Wed Apr 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 112-0646946-7/1/1 (Fri Feb 04 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources