FDA 483 - Medartis Inc. - September 03, 2021

Nextremity Solutions in Warsaw, IN, was inspected by the FDA, resulting in three observations. The inspection revealed significant issues with the control of nonconforming products, inadequate investigation of device complaints, and an insufficient risk analysis system that allowed for high levels of acceptable risk without proper justification. These findings indicate serious deficiencies in the firm's quality management system for medical devices.