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Import refusals
/ 620-2006433-3/1/1
620-2006433-3/1/1
SynCardia Systems LLC — FEI 3003761017
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))
Compliance actions
Warning Letter (537226)
(Tue Apr 03 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
Refusal Details
Date
December 28, 2011
Country
United States
Product Category
Devices
Product Code
74LOZ HEART, ARTIFICIAL
Charges
118,341,508