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FDA Inspection 1100450 — Edwards Lifesciences, LLC

Edwards Lifesciences, LLC — FEI 2015691

The FDA completed an inspection of Edwards Lifesciences, LLC on August 19, 2019 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
August 19, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Bioresearch Monitoring
Location
Irvine, CA (United States)

Additional Details

Sponsor, Contract Research Organization

Facility

Other inspections at this facility

  • 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))
  • 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))

Recent compliance actions

FDA data resources