# FDA 483 - CMI Health, Inc. - May 30, 2025

Source: https://www.keypedia.com/records/483/cmi-health-inc/aa9d4738-b2c0-467e-ae7e-4befc3c8c311

> FDA 483 for CMI Health, Inc. on May 30, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CMI Health, Inc.
- Inspection Date: 2025-05-30
- Product Type: device
- Office Name: Atlanta District Office
- Summary: CMI Health, Inc. in Alpharetta, GA, was cited with five observations on a Form 483, indicating significant deficiencies in their quality management system for medical devices. The inspection revealed inadequate complaint handling procedures, a complete absence of design controls, and failures in supplier evaluation, internal audits, and document control. These issues collectively point to a systemic lack of adherence to regulatory requirements.

## Related Officers

- [Dawn M. Braswell](https://www.keypedia.com/people/dawn-m-braswell/6a66fdbb-fff8-4b4b-9f06-320464957b87)

Company: https://www.keypedia.com/companies/cmi-health-inc/5ba1577f-6075-401e-b1c4-d1cbb3a97581

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7