# FDA 483 - Enthermics Medical Systems, Inc. - July 17, 2025

Source: https://www.keypedia.com/records/483/enthermics-medical-systems-inc/5592e4d9-0371-4df7-a5a5-ba21ec52f1e9

> FDA 483 for Enthermics Medical Systems, Inc. on July 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Enthermics Medical Systems, Inc.
- Inspection Date: 2025-07-17
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Enthermics Medical Systems, Inc. in Menomonee Falls, WI, a contract manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for in-process product acceptance, corrective and preventive actions, device history records, and control of non-conforming products. These issues indicate a lack of robust quality controls for their medical device manufacturing processes.

## Related Documents

- [483 - 2021-09-16](https://www.keypedia.com/records/483/enthermics-medical-systems-inc/72323f18-7e27-4cfe-9e0c-05db7d3f750c)

## Related Officers

- [Shawn Choi](https://www.keypedia.com/people/shawn-choi/77845db3-46a3-4d0f-b94c-428bc251c0dc)

Company: https://www.keypedia.com/companies/enthermics-medical-systems-inc/b7533b0f-4bb5-436c-9743-dd8535baff3f

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