FDA 483 - Arxium Inc - April 01, 2024

An FDA inspection of Arxium Inc in Buffalo Grove, IL, a contract manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for corrective and preventive actions (CAPA), resulting in delayed completion of CAPA plans. Additionally, procedures for receiving, reviewing, and evaluating customer complaints were not adequately established, leading to untimely processing and investigation of multiple complaints.