FDA 483 - Cordis US Corp - June 29, 2022

An FDA inspection of Cordis US Corp in Miami Lakes, FL, revealed significant deficiencies in the firm's design control procedures for their (b)(4) Stent, particularly concerning a new pediatric indication. Observations cited inadequate establishment of procedures for design verification, design input documentation, design validation, and design review. These issues indicate a lack of robust controls to ensure the safety and effectiveness of the device for its intended use.