Smiths Medical ASD, Inc. – FDA 483, Apr 30, 2021

An FDA inspection of Smiths Medical ASD Inc. in Minneapolis, MN, revealed significant deficiencies in the firm's quality system, particularly concerning design validation, corrective and preventive actions, and complaint handling for their Medfusion infusion pumps. The inspection found unvalidated software combinations, inadequate CAPA implementation and verification, and failures to properly investigate and report adverse events, some of which were associated with patient deaths and serious injuries. These issues indicate a systemic breakdown in ensuring device safety and effectiveness.