# FDA 483 - CM Technologies, Inc - February 10, 2025

Source: https://www.keypedia.com/records/483/cm-technologies-inc/ff783572-32d1-469b-adaa-e566d4f2e58c

> FDA 483 for CM Technologies, Inc on February 10, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CM Technologies, Inc
- Inspection Date: 2025-02-10
- Product Type: other
- Office Name: Dallas District Office
- Summary: CM Technologies, Inc. in Carrollton, TX, an initial importer, was cited by the FDA for failing to submit Medical Device Reports (MDRs) for serious injuries. The firm did not report multiple instances of severe rectal bleeding and other serious patient outcomes associated with its marketed fecal management system. This indicates a significant lapse in post-market surveillance and reporting requirements.

## Related Officers

- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)
- [Elizabeth A. Krolczyk](https://www.keypedia.com/people/elizabeth-a-krolczyk/ecf57c43-b88d-4f84-962b-9067eaad4a7c)

Company: https://www.keypedia.com/companies/cm-technologies-inc/d6643e8e-c10b-4bd1-a414-6066f0bd4d90

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9