FDA 483 - SunMed Holdings, LLC - August 30, 2023

An FDA inspection of SunMed Holdings, LLC in Grand Rapids, MI, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, control nonconforming products, and conduct proper risk analyses for their AirFlow Manual Resuscitator/Ventilators, which were found to exceed ISO standards for dead space. These issues raise concerns about the safety and effectiveness of their medical devices.