# FDA 483 - Radiation Products Design,Inc - March 04, 2026

Source: https://www.keypedia.com/records/483/radiation-products-designinc/5a47d0f2-f328-4312-8719-142e40854862

> FDA 483 for Radiation Products Design,Inc on March 04, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Radiation Products Design,Inc
- Inspection Date: 2026-03-04
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Radiation Products Design, Inc. in Albertville, MN, revealed a significant deficiency in the firm's quality system. The company failed to adequately document processes for risk management in product realization, specifically lacking formal risk assessments for products like tungsten eye shields. This indicates a moderate severity issue related to quality system controls.

## Related Documents

- [483 - 2026-03-31](https://www.keypedia.com/records/483/radiation-products-designinc/41b88702-da1a-4ea9-bbff-6a6d1a5f026c)

## Related Officers

- [Investigator ](https://www.keypedia.com/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.keypedia.com/companies/radiation-products-designinc/bf052072-9353-43aa-a28a-712fe41c9c96

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d