FDA 483 - Keranetics Inc. - February 06, 2025

Keranetics Inc. in Winston Salem, NC, a specification developer, was inspected by the FDA from February 5-6, 2025. The inspection revealed significant deficiencies in the firm's quality system, including a lack of written Medical Device Reporting (MDR) procedures, inadequate complaint handling, failure to conduct management reviews, and absence of quality audits. These findings indicate a broad failure to maintain essential quality system controls.