Bionix, Llc – FDA 483, Jul 14, 2026

An FDA inspection of Bionix, Llc in Maumee, OH, a medical device manufacturer, revealed significant deficiencies across its quality management system. The firm failed to adequately perform design and development verification, establish purchasing controls, and properly evaluate and control critical suppliers. Additionally, issues were noted in maintaining risk management records, applying a risk-based approach to quality, documenting quality system procedures, and ensuring complete complaint investigation records, including MDR reportability and UDI capture.