# FDA 483 - Brius Technologies Inc. - October 07, 2024

Source: https://www.keypedia.com/records/483/brius-technologies-inc/2ce040ae-2611-4eae-a18e-bd43714395b1

> FDA 483 for Brius Technologies Inc. on October 07, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brius Technologies Inc.
- Inspection Date: 2024-10-07
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of Brius Technologies Inc. in Carrollton, TX, revealed significant deficiencies in their quality system for medical devices. The firm failed to timely report Medical Device Reports (MDRs), inadequately documented corrective and preventive actions (CAPAs), and did not properly investigate product complaints or manage nonconforming products. Additionally, equipment maintenance activities lacked proper documentation and clear instructions.

## Related Officers

- [Katlin N. Stubbs](https://www.keypedia.com/people/katlin-n-stubbs/27d70db1-a2e9-4254-a721-c6de655f7626)
- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/brius-technologies-inc/51543c21-de25-4892-aab7-96e35225aa42

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