FDA 483 - Artivion, Inc - March 31, 2023

Artivion, Inc. in Kennesaw, GA, was inspected and cited for significant deficiencies across its quality system. The inspection revealed inadequate procedures for controlling nonconforming products, insufficient documentation and approval of process validation activities, and poorly established corrective and preventive action procedures. Additionally, design verification failed to ensure that design outputs met input requirements for product labeling.