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1093187

Edwards Lifesciences, LLC — FEI 2015691

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 14, 2019
Fiscal Year
2019
Product Type
Devices
Project Area
Compliance: Devices
Location
Irvine, CA (United States)

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))
  • 1100450 (NAI Mon Aug 19 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 959741 (NAI Fri Feb 12 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 949892 (VAI Fri Nov 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))

Recent compliance actions

Citations

IDCFRDescription
1471321 CFR 820.198(a)Lack of or inadequate complaint procedures
313021 CFR 820.100(a)Lack of or inadequate procedures
368021 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures