Genesis Software Innovations LLC.March 13, 2025

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

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Record Details

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.

Company: Genesis Software Innovations LLC.
Inspection Date: March 13, 2025
Product Type: Device
Office: Detroit District Office
Person: David J. Gasparovich

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ID · 6efcddcd-15d9-41e2-821a-eb47e0cc0305