Koven Technology, Inc. – FDA 483, Feb 6, 2026

An FDA inspection of Koven Technology, Inc., a manufacturer and distributor of medical devices including fetal dopplers, revealed significant quality system deficiencies. The firm failed to document design changes for expanding fetal indications of use, inadequately maintained complaint records, and lacked proper criteria for evaluating and managing a critical foreign supplier. Additionally, risk management analyses for fetal dopplers did not adequately assess fetal-specific hazards.