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FDA Inspection 1079700 — SynCardia Systems LLC

SynCardia Systems LLC — FEI 3003761017

The FDA completed an inspection of SynCardia Systems LLC on November 29, 2018 in Tucson, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
November 29, 2018
Fiscal Year
2019
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Tucson, AZ (United States)

Facility

Other inspections at this facility

  • 1022176 (OAI Fri Aug 18 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 922825 (VAI Fri Apr 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 826059 (NAI Thu Mar 28 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 746232 (VAI Fri Sep 23 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources