FDA 483 - Custom Wire Technologies Inc - July 17, 2025

An FDA inspection of Custom Wire Technologies, Inc. in Port Washington, WI, revealed significant deficiencies in their quality system for manufacturing Class 2 medical device accessories. The firm failed to adequately control nonconforming product, document in-process inspections, validate processes, and maintain environmental controls, with some issues being repeat observations. These findings indicate a need for comprehensive corrective actions to ensure product quality and safety.