FDA 483 - EUROMI S.A. - July 31, 2025

Euromi S.A., a medical device manufacturer, received a Form FDA 483 for significant quality system deficiencies. The inspection revealed inadequate procedures for corrective/preventive actions, missing acceptance procedures for their EVA sp6 Lipoplasty Suction System, and insufficient documentation of manufacturing process controls. Furthermore, the firm failed to maintain MDR event files and did not provide required UDI information to the GUDID.