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FDA Inspection 959741 — Edwards Lifesciences, LLC

Edwards Lifesciences, LLC — FEI 2015691

The FDA completed an inspection of Edwards Lifesciences, LLC on February 12, 2016 in Irvine, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). Product area: Devices.

Inspection Details

Classification
No Action Indicated (NAI) (NAI)
End Date
February 12, 2016
Fiscal Year
2016
Product Type
Devices
Project Area
Postmarket Assurance: Devices
Location
Irvine, CA (United States)

Facility

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  • 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))
  • 949892 (NAI Fri Nov 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

FDA data resources