Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 2015691.
Observations1
Issue DateNovember 18, 2013
StatusNo Warning Letter
Related Inspections10
Establishment Details
Firm
Edwards Lifesciences, LLC
Location
Irvine, California, United States
FEI Number
2015691
Product Type
Devices
Issue Date
November 18, 2013
Country
United States
Inspection History, 2013 to 2024
NAI6
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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