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EDWARDS LIFESCIENCES LLC — FDA Facility Profile

FEI 2015691

EDWARDS LIFESCIENCES LLC is an FDA-registered facility (FEI 2015691) located in IRVINE, CA, US. RegDataLab tracks 10 or more FDA inspections and 1 compliance action at this facility.

Facility Details

Location
IRVINE, CA (US)
Registration Expires
N/A
Operations
Source
device

Recent inspections

  • 1229680 (NAI Thu Aug 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1194166 (NAI Tue Dec 06 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1100450 (NAI Mon Aug 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1093187 (VAI Fri Jun 14 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 959741 (NAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949892 (NAI Fri Nov 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 947318 (NAI Tue Nov 03 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 855673 (VAI Mon Nov 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 842157 (NAI Thu Jul 18 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 839415 (NAI Thu Jun 13 2013 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • WC1-7182821-1/3811/1 (Wed Oct 07 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • WC1-7182807-0/351/1 (Fri Sep 25 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • WC1-7182830-2/1281/1 (Tue Sep 22 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • WC1-7182228-9/11/1 (Thu Aug 13 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • WC1-7182368-3/2771/1 (Tue Aug 11 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AQK-0001189-0/1/2 (Tue May 17 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • AQK-0001189-0/1/1 (Tue May 17 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)
  • 310-5195213-8/2/1 (Mon Nov 18 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources