# FDA 483 - TreyMed, Inc. - August 27, 2025

Source: https://www.keypedia.com/records/483/treymed-inc/7cd7f875-3f7c-4487-95a8-e387402128bb

> FDA 483 for TreyMed, Inc. on August 27, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: TreyMed, Inc.
- Inspection Date: 2025-08-27
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: TreyMed, Inc. in Sussex, WI, was inspected from August 25-27, 2025, and received one observation. The inspection revealed deficiencies in the firm's procedures for controlling nonconforming medical devices. Specifically, documentation and evaluation processes for nonconforming products were found to be inadequate.

## Related Documents

- [WARNING_LETTER - 2014-10-21](https://www.keypedia.com/records/warning_letter/treymed-inc/c8fb6360-9c84-4438-891f-69f5b7e36de6)

## Related Officers

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

Company: https://www.keypedia.com/companies/treymed-inc/145039dc-c808-4669-9fb7-839988c2c8e4

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