# FDA 483 - Bradshaw Medical, Inc. - August 15, 2017

Source: https://www.keypedia.com/records/483/bradshaw-medical-inc/f7409669-0ee6-45ec-9cef-886e37759355

> FDA 483 for Bradshaw Medical, Inc. on August 15, 2017. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bradshaw Medical, Inc.
- Inspection Date: 2017-08-15
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Bradshaw Medical, Inc. in Kenosha, WI, a medical device manufacturer, was cited for significant deficiencies across three observations during an FDA inspection. The firm failed to adequately establish procedures for design changes, corrective and preventive actions (CAPA), and complaint handling, leading to issues with product quality and regulatory compliance. These findings indicate a systemic breakdown in their quality management system.

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## Related Officers

- [investigator](https://www.keypedia.com/people/michelle-j-glembin/e58f4652-d09f-41a7-941d-335c7b5338ad)

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