# FDA 483 - Bradshaw Medical, Inc. - February 28, 2022

Source: https://www.keypedia.com/records/483/bradshaw-medical-inc/6829cf05-c032-4bce-bd62-e833cef26327

> FDA 483 for Bradshaw Medical, Inc. on February 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bradshaw Medical, Inc.
- Inspection Date: 2022-02-28
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Bradshaw Medical, Inc. in Kenosha, WI, a medical device contract manufacturer, was inspected and cited for three significant issues. These included inadequate procedures for acceptance activities related to device durability testing, failure to submit a timely Medical Device Report (MDR) for a malfunctioning orthopedic device, and not reporting a field corrective action for devices with incorrect materials to the FDA. Two of the three observations were repeat findings from a previous inspection.

## Related Documents

- [483 - 2017-08-15](https://www.keypedia.com/records/483/bradshaw-medical-inc/f7409669-0ee6-45ec-9cef-886e37759355)
- [483 - 2025-09-12](https://www.keypedia.com/records/483/bradshaw-medical-inc/90e060f2-d35e-4895-b606-d18553a0416a)

## Related Officers

- [Nicholas Z. Lu](https://www.keypedia.com/people/nicholas-z-lu/17448aca-e316-424c-b7b2-88c8baffc359)
- [investigator](https://www.keypedia.com/people/nicholas-t-domer/8e2d2ff5-b0da-4b0d-bd65-492a49ae1035)

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