FDA 483 - Genesis Software Innovations LLC. - March 13, 2025

Genesis Software Innovations LLC, a medical device firm in Grand Rapids, MI, was cited for failing to validate software used in its quality system. The inspection revealed a lack of established processes for addressing active cybersecurity vulnerability threats to their Preview Shoulder software device, resulting in multiple unaddressed high-severity findings. This indicates a significant deficiency in their quality management system regarding software integrity.