Ethos Emergency Preparedness, LLC – FDA 483, Oct 7, 2025

Ethos Emergency Preparedness, LLC, a manufacturer and specification developer of medical devices in Saint Louis, MO, was cited for significant quality system deficiencies during an FDA inspection. The inspection revealed a severe lack of established and documented procedures across multiple critical areas, including design control, corrective and preventive actions, unique device identification, acceptance activities, purchasing controls, and document control. These issues indicate a fundamental breakdown in the firm's quality management system for its Class I and II medical devices.