FDA WARNING_LETTER - Koven Technologies, Inc. - February 06, 2026

On July 21, 2026, the FDA issued a Warning Letter to Koven Technologies, Inc. following an inspection of its Saint Louis, Missouri facility conducted from February 2 to February 6, 2026. The inspection identified significant violations of the Federal Food, Drug, and Cosmetic Act and the Quality Management System Regulation (21 CFR Part 820), particularly regarding the Bidop 3 and Bidop 7 Doppler devices. Key issues included the company’s failure to document and validate design changes when expanding the Bidop 3’s intended use to include fetal applications without obtaining the necessary regulatory clearance. The FDA highlighted a critical lack of risk management, noting that the firm failed to evaluate hazards specific to fetal use, such as ultrasound energy exposure and the potential for clinical misinterpretation of heartbeats. Furthermore, Koven Technologies demonstrated inadequate oversight of its contract manufacturers, failing to audit high-risk suppliers or maintain documentation for changes made by external partners. The firm also failed to process numerous reported device failures as formal complaints, neglecting required investigations into performance and reliability. While the company has initiated some corrective actions and a voluntary recall, the FDA found current efforts insufficient to address systemic failures. Koven Technologies is required to provide a comprehensive written response within 15 business days outlining specific steps taken to correct these violations and prevent their recurrence. Failure to comply may lead to regulatory actions, including product seizures, injunctions, or civil financial penalties.