FDA 483 - Medfaxx, Inc. - July 10, 2019

An FDA inspection of MedXXX, Inc. in Wake Forest, NC, revealed significant deficiencies in their quality system. The firm failed to establish critical procedures for design control, medical device reporting, corrective and preventive actions, and complaint handling. Additionally, management did not adequately review the quality system's suitability and effectiveness, indicating a broad lack of foundational quality system controls.