FDA 483 - Industrial Woodworking Corp. - March 12, 2025

An FDA inspection of Industrial Woodworking Corp. in Zeeland, MI, revealed significant deficiencies across its quality system, particularly in process validation and control for medical device manufacturing. The firm failed to adequately validate key processes, establish proper process controls, and maintain accurate device history records. These issues indicate a systemic lack of adherence to quality system requirements, posing potential risks to product quality and patient safety.