FDA 483 - Ethos Emergency Preparedness, LLC - February 28, 2025

An FDA inspection of Ethos Emergency Preparedness, LLC in Saint Louis, MO, a manufacturer of the Complete Emergency Kit (Class II medical device), revealed significant deficiencies. The firm failed to establish and maintain an adequate organizational structure and implement required quality system procedures per 21 CFR 820. Additionally, the company did not apply unique device identifiers (UDI) to its medical devices or packaging, nor did it develop written Medical Device Reporting (MDR) procedures.