FDA 483 - Edwards Lifesciences, LLC - April 11, 2014

Edwards Lifesciences, LLC, a medical device manufacturer in Draper, UT, was cited for numerous quality system deficiencies during an FDA inspection. The inspection revealed significant issues with process validation, corrective and preventive actions, production process monitoring, and control of nonconforming products. These findings indicate a systemic lack of adequately established procedures across critical manufacturing and quality control areas.