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TERUMO CARDIOVASCULAR SYSTEMS CORPORATION — FDA Facility Profile

FEI 1828100

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION is an FDA-registered facility (FEI 1828100) located in ANN ARBOR, MI, US. RegDataLab tracks 10 or more FDA inspections and 1 compliance action at this facility.

Facility Details

Location
ANN ARBOR, MI (US)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 1147794 (NAI Wed Jul 14 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1111814 (NAI Fri Oct 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1031879 (NAI Tue Oct 03 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996655 (NAI Wed Dec 07 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 971672 (NAI Fri May 13 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 912380 (NAI Fri Jan 30 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 868020 (OAI Mon Feb 17 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 840285 (NAI Fri Jul 19 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 802832 (OAI Fri Sep 28 2012 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 636280 (OAI Mon Mar 29 2010 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

  • Injunction (138) (Tue Mar 29 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-2626188-3/11/1 (Wed May 26 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources