Comfortland Medical, Inc. – FDA 483, Jun 12, 2026

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.