Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1713910.
Observations13
Issue DateJuly 10, 2015
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections8
Establishment Details
Firm
Edwards Lifesciences, LLC
Location
Draper, Utah, United States
FEI Number
1713910
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
July 10, 2015
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.
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