# RSI Technology Group, LLC – FDA 483, Apr 17, 2026

Source: https://www.keypedia.com/records/483/rsi-technology-group-llc/4c9adc59-bf66-4107-b0c2-4b1dc8d3a452

> FDA 483 for RSI Technology Group, LLC on April 17, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RSI Technology Group, LLC
- Inspection Date: 2026-04-17
- Product Type: device
- Office Name: Dallas District Office
- Summary: An FDA inspection of RSI Technology Group, LLC, a medical device specification developer and manufacturer, revealed significant deficiencies across its quality management system. The firm failed to adequately implement risk management, production controls, and design controls for its sterile products, ProteX and NovoSorT. These findings indicate a lack of adherence to established procedures and regulatory requirements, posing potential risks to product quality and patient safety.

## Related Documents

- [483 - 2023-02-22](https://www.keypedia.com/records/483/rsi-technology-group-llc/97c8ef17-646b-4fd9-b4aa-c63b64d90649) — date: February 22, 2023

## Related Officers

- [Jacey Roy](https://www.keypedia.com/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)

Company: https://www.keypedia.com/companies/rsi-technology-group-llc/8e90ed79-f168-457b-b3fb-acffa44064c5

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