Artivion, Inc – FDA 483, Aug 8, 2018

An FDA inspection of Cryolife, Inc. in Kennesaw, GA, revealed significant deficiencies in design validation for their patch products. The firm also failed to properly design, maintain, and monitor manufacturing equipment, including issues with preventive maintenance schedules and malfunctioning freezer alarms for cryopreserved allografts. These findings indicate a lack of adequate quality system controls for device manufacturing and tissue storage.