# Bradshaw Medical, Inc. – FDA 483, Sep 12, 2025

Source: https://www.keypedia.com/records/483/bradshaw-medical-inc/90e060f2-d35e-4895-b606-d18553a0416a

> FDA 483 for Bradshaw Medical, Inc. on September 12, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bradshaw Medical, Inc.
- Inspection Date: 2025-09-12
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Bradshaw Medical, Inc. in Kenosha, WI, a medical device manufacturer, identified significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions, control of nonconforming products, and routine equipment maintenance. These issues indicate a lack of robust controls necessary for ensuring product quality and compliance with regulatory requirements.

## Related Documents

- [483 - 2022-02-28](https://www.keypedia.com/records/483/bradshaw-medical-inc/6829cf05-c032-4bce-bd62-e833cef26327) — date: February 28, 2022
- [483 - 2017-08-15](https://www.keypedia.com/records/483/bradshaw-medical-inc/f7409669-0ee6-45ec-9cef-886e37759355) — date: August 15, 2017

## Related Officers

- [Shuana H. Xiong](https://www.keypedia.com/people/shuana-h-xiong/45ee2b1d-fbb8-452e-a218-8d79e8425fc8)

Company: https://www.keypedia.com/companies/bradshaw-medical-inc/9a789895-c4a2-4b8d-9ae9-f2e2457ccb88

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