FDA 483 - Fox Converting,Inc - November 19, 2021

An FDA inspection of Fox Converting, Inc. in Green Bay, WI, a medical device manufacturer, revealed significant and systemic deficiencies in its quality management system. The firm failed to adequately establish procedures for design control, process validation, corrective and preventive actions, acceptance activities, nonconforming product control, medical device reporting, device history records, and quality audits. Notably, many of these observations were repeats from a 2011 inspection, indicating persistent non-compliance.