FDA 483 - Edwards Lifesciences Technology SARL - June 11, 2019

Edwards Lifesciences Technology SARL in Anasco, PR, a medical device manufacturer, was cited for inadequate documentation of corrective and preventive action (CAPA) activities. The firm failed to adequately justify the bounding of a field action related to incorrect assembly of Swan Ganz thermodilution catheters and did not investigate the root cause of an identified equipment discrepancy. These deficiencies indicate a lack of thoroughness in their quality system's handling of product issues and corrective measures.