FDA 483 - Compass Health Brands (Corporate Office) - December 19, 2022

Compass Health Brands (Corporate Office) in Middleburg Heights, OH, an initial importer, was cited for three observations during an FDA inspection. The firm failed to establish corrective and preventive action procedures, did not submit timely Medical Device Reports for serious injuries, and failed to report device correction and removal actions to the FDA within the required timeframe. These issues indicate significant deficiencies in the firm's quality system and post-market surveillance processes.