Compass Health Brands (Corporate Office) – FDA 483, Oct 7, 2021

The FDA inspection of Compass Health Brands (Corporate Office) in Middleburg Heights, OH, identified seven significant violations related to quality system regulations for medical devices. The firm failed to timely report a Class I recall, inadequately documented corrective actions for serious injuries and safety issues, and exhibited deficiencies in risk analysis, design change procedures, and supplier management. These issues indicate a lack of robust controls over product quality and safety across various device types.