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

Source: https://www.keypedia.com/records/483/medical-informatics-corp/9d91b060-dcbe-4e9d-b8d9-68163ee53687

> FDA 483 for Medical Informatics Corp. on March 27, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Informatics Corp.
- Inspection Date: 2026-03-27
- Product Type: device
- Office Name: Dallas District Office
- Summary: 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.

## Related Documents

- [483 - 2019-08-02](https://www.keypedia.com/records/483/medical-informatics-corp/dcd223a0-5874-4480-bf4e-03f9c02ac41e)

## Related Officers

- [Jocelyn C. Turner](https://www.keypedia.com/people/jocelyn-c-turner/7e39f6e0-9750-4460-8a4e-27ee9306b77e)

Company: https://www.keypedia.com/companies/medical-informatics-corp/3af5f5fc-e31f-4ac1-973a-757494587100

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9