# FDA 483 - MedTorque Inc. - September 25, 2025

Source: https://www.keypedia.com/records/483/medtorque-inc/81c27e78-2d52-4746-b72d-59aa3f10b957

> FDA 483 for MedTorque Inc. on September 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MedTorque Inc.
- Inspection Date: 2025-09-25
- Product Type: device
- Office Name: Chicago District Office
- Summary: An FDA inspection of Inland Midwest Corporation, a contract manufacturer of medical devices in Elmhurst, IL, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures for controlling non-conforming products, specifically lacking requirements for evaluating nonconformances and determining when investigations are necessary. Additionally, a critical manufacturing process (passivation) was not adequately validated, with out-of-tolerance results accepted without proper justification.

## Related Officers

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

Company: https://www.keypedia.com/companies/medtorque-inc/3efef07d-7576-429e-933b-b7b1e56915e8

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669