Home / Compliance actions / 537226

Warning Letter

Case 537226 — FEI 3003761017

Facility

Recent inspections

  • 1079700 (NAI Thu Nov 29 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1022176 (VAI 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))

Action Details

Facility
SynCardia Systems LLC
Date
April 3, 2018
Fiscal Year
2018
Product Type
Devices
Center
CDRH
Location
Tucson, AZ (United States)