# FDA 483 - Comfortland Medical, Inc. - June 12, 2026

Source: https://www.keypedia.com/records/483/comfortland-medical-inc/339b6877-2a8a-46e4-aece-0b278b5abae5

> FDA 483 for Comfortland Medical, Inc. on June 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Comfortland Medical, Inc.
- Inspection Date: 2026-06-12
- Product Type: device
- Office Name: Atlanta District Office
- Summary: Comfortland Medical, Inc. in Mebane, NC, a specification developer, was cited for significant deficiencies across its quality management system during an FDA inspection. Observations included failures in documenting and maintaining quality processes, design and development files, risk management, complaint handling, and supplier controls. The firm also lacked proper Medical Device Reporting procedures and Unique Device Identifiers on device labels.

## Related Officers

- [Christopher B. May](https://www.keypedia.com/people/christopher-b-may/b2173a59-d37b-41f1-aa39-eefd854722b8)

Company: https://www.keypedia.com/companies/comfortland-medical-inc/2289b15e-d384-4916-8d26-ab5859bc84e8

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