FDA 483 - Curonix LLC - February 15, 2019

St.Jude Technologies Inc. in Pompano Beach, FL, a medical device manufacturer, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, design changes, and rework of nonconforming products. These issues led to inadequate evaluation of product deficiencies, unreported medical device events, and a lack of proper control over product modifications and returned goods.