FDA 483 - Custom Wire Technologies Inc - February 18, 2022

An FDA inspection of Custom Wire Technologies Inc, a medical device manufacturer in Port Washington, WI, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures related to acceptance activities, control of nonconforming product, process validation, environmental controls for their cleanroom, and corrective and preventive actions. These issues indicate a lack of robust controls to ensure product quality and compliance with regulatory requirements.