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Warning Letter

Case 87305 — FEI 2015691

Facility

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))

Action Details

Facility
Edwards Lifesciences, LLC
Date
March 1, 2010
Fiscal Year
2010
Product Type
Devices
Center
CDRH
Location
Irvine, CA (United States)