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SYNCARDIA SYSTEMS, LLC — FDA Facility Profile

FEI 3003761017

SYNCARDIA SYSTEMS, LLC is an FDA-registered facility (FEI 3003761017) located in TUCSON, AZ, US. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
TUCSON, AZ (US)
Registration Expires
N/A
Operations
Source
device

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

Import refusals

  • 620-2006433-3/1/1 (Wed Dec 28 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources