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FDA Inspection 802832 — Terumo Cardiovascular Systems Corporation

Terumo Cardiovascular Systems Corporation — FEI 1828100

The FDA completed an inspection of Terumo Cardiovascular Systems Corporation on September 28, 2012 in Ann Arbor, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). Product area: Devices.

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
September 28, 2012
Fiscal Year
2012
Product Type
Devices
Project Area
Compliance: Devices
Location
Ann Arbor, MI (United States)

Facility

Other inspections at this facility

  • 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))

Recent compliance actions

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

FDA data resources