FDA 483 - KX Medical Inc - January 21, 2025

During an inspection conducted from January 15 to January 21, 2025, the U.S. Food and Drug Administration issued a Form FDA-483 to KX Medical Inc., a contract manufacturer of medical devices. The inspection identified a significant issue related to the company's quality system, specifically concerning its procedures for acceptance activities. The primary observation noted that KX Medical Inc. has not adequately established procedures for the final release of its Class I and Class II medical devices. The firm's 'Monitoring and Measurement of Product' procedure (QSP.022, Rev 01) lacks a critical element: it fails to designate a specific individual, either by name or job title, who is authorized to perform the final review and release of products. Furthermore, the procedure does not mandate the required signature(s) of such a designated individual for final product release. This deficiency indicates a deviation from the quality system requirements enforced by the Federal Food, Drug and Cosmetic Act. The company is now required to implement corrective actions to address these procedural shortcomings. During the inspection, KX Medical Inc. promised to correct the identified observation, signaling their commitment to rectifying the non-compliant practices to ensure proper control over product acceptance and release.