# FDA 483 - Custom Wire Technologies Inc - July 17, 2025

Source: https://www.keypedia.com/records/483/custom-wire-technologies-inc/bc838153-0d2c-4dc2-b60c-a7c8243ece78

> FDA 483 for Custom Wire Technologies Inc on July 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Custom Wire Technologies Inc
- Inspection Date: 2025-07-17
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Custom Wire Technologies, Inc. in Port Washington, WI, revealed significant deficiencies in their quality system for manufacturing Class 2 medical device accessories. The firm failed to adequately control nonconforming product, document in-process inspections, validate processes, and maintain environmental controls, with some issues being repeat observations. These findings indicate a need for comprehensive corrective actions to ensure product quality and safety.

## Related Documents

- [483 - 2022-02-18](https://www.keypedia.com/records/483/custom-wire-technologies-inc/c567e5fb-ac3e-485c-a954-c7246a632b06)

## Related Officers

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

Company: https://www.keypedia.com/companies/custom-wire-technologies-inc/09bf8a11-5205-48a3-b3e4-9ce84eed4dbf

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