FDA 483 - Ekso Bionics Inc. - December 21, 2023

During an inspection, Ekso Bionics Inc. in Macedonia, OH, a medical device manufacturer, was cited for inadequate procedures to control nonconforming product. The firm's procedures failed to clearly define the assignment and use of nonconforming codes for data analysis and lacked a system to link nonconformances to process risk analysis. This indicates a significant deficiency in their quality management system.