FDA 483 - Medical Informatics Corp. - March 27, 2026

Medical Informatics Corp. in Houston, TX, a software manufacturer, was cited for significant deficiencies in its quality management system during an FDA inspection. The firm failed to adequately apply risk-based approaches, document design and development procedures, ensure software revalidation, maintain MDR procedures, and verify the effectiveness of corrective actions. These issues indicate a systemic lack of control over critical processes for their Sickbay Clinical Platform.