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 1713910.
Observations3
Issue DateMay 20, 2016
StatusNo Warning Letter
Related Inspections8
Establishment Details
Firm
Edwards Lifesciences, LLC
Location
Draper, Utah, United States
FEI Number
1713910
Product Type
Devices
Issue Date
May 20, 2016
Country
United States
Inspection History, 2009 to 2021
NAI5
VAI2
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.