FDA 483 - Electro Medical Systems, LLC - October 21, 2025

An FDA inspection of Electro Medical Systems, LLC in Southlake, TX, a remanufacturer and repackager/relabeler, revealed significant deficiencies in its quality system. Observations included inadequate supplier control, poor document control practices, and a lack of documented personnel training. These issues suggest a need for comprehensive corrective actions to ensure compliance with regulatory requirements.