FDA 483 - CXMedUS, Inc. - April 06, 2023

CXMEDUS, Inc. in Grand Blanc, MI, a medical device establishment, was inspected by the FDA, resulting in five observations. The inspection revealed significant deficiencies in the firm's quality system, primarily concerning the lack of documented and implemented procedures for complaint handling, medical device reporting, corrective and preventive actions, supplier management, and incoming product acceptance. These issues indicate a fundamental breakdown in the firm's ability to ensure product quality and compliance with regulatory requirements.