FDA 483 - InfuTronix LLC - February 15, 2022

An FDA inspection of InfuTronix LLC in Natick, MA, revealed five significant observations regarding their quality system for medical devices. The firm failed to adequately establish procedures for corrective and preventive actions, properly handle and investigate product complaints, and ensure design validation for their Nimbus infusion pumps. Additionally, deficiencies were noted in supplier management and the timely submission of Medical Device Reports for serious malfunctions, including repeat observations.