FDA 483 - Cancer Diagnostics Inc. - April 04, 2025

Cancer Diagnostics Inc. in Durham, NC, was inspected by the FDA from April 2-4, 2025, and received six observations, many of which were repeat findings from a 2019 inspection. The firm demonstrated significant deficiencies across its Quality Management System, including failures in CAPA, design control, purchasing control, complaint handling, internal audits, and management review. These issues indicate a systemic lack of implementation for critical quality procedures for their Class II medical devices.