Source: FDA record for this establishment. FDA publishes inspections or enforcement actions for this establishment, listed further down this page, but we have not matched this particular Form 483 to a document or an inspection date FDA has released. It stays out of the default view for that reason. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 2015691.
Observations1
Issue DateSeptember 16, 2009
StatusNo Warning Letter
Related Inspections10
Establishment Details
Firm
Edwards Lifesciences, LLC
Location
Irvine, California, United States
FEI Number
2015691
Product Type
Devices
Issue Date
September 16, 2009
Country
United States
Inspection History, 2013 to 2024
NAI6
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.