Home / Import refusals / 620-2006433-3/1/1

FDA Import Refusal 620-2006433-3/1/1 — SynCardia Systems LLC

SynCardia Systems LLC — FEI 3003761017

The FDA refused shipment 620-2006433-3/1/1 from SynCardia Systems LLC (United States) on December 28, 2011. The refused product falls under Devices — HEART, ARTIFICIAL. Cited charges: 118,341,508

Refusal Details

Date
December 28, 2011
Country
United States
Product Category
Devices
Product Code
74LOZ HEART, ARTIFICIAL
Charges
118,341,508

Recent inspections

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

Compliance actions

FDA data resources