FDA 483 - Jedmed Instrument Company - December 05, 2025

Jedmed Instrument Company, a manufacturer of ENT and Ophthalmologic medical devices in Saint Louis, MO, was cited for significant deficiencies in its quality system. The inspection revealed failures in maintaining accessible design history and complaint records, inadequate complaint handling and investigation, insufficient purchasing controls for contract manufacturers, and a lack of proper employee training for complaint determination. These issues indicate systemic problems in ensuring product quality and regulatory compliance.