# FDA 483 - Medical Informatics Corp. - August 02, 2019

Source: https://www.globalkeysolutions.net/records/483/medical-informatics-corp/dcd223a0-5874-4480-bf4e-03f9c02ac41e

> FDA 483 for Medical Informatics Corp. on August 02, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Informatics Corp.
- Inspection Date: 2019-08-02
- Product Type: device
- Office Name: Dallas District Office
- Summary: Medical Informatics Corp. in Houston, TX, a medical device manufacturer, received a Form FDA 483 with seven observations following an inspection. The observations highlight significant deficiencies in the firm's quality system, including inadequate procedures for complaint handling, MDR reporting, employee training, and labeling control. Additionally, issues were noted with device software validation documentation and the completeness of risk analysis, indicating a need for comprehensive improvements in their quality management system.

## Related Officers

- [Ellen J. Tave](https://www.globalkeysolutions.net/people/ellen-j-tave/a70cd3ed-957f-471b-82ff-24ca7c65bc10)

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

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