FDA 483 - EUROMI S.A. - March 02, 2023

EUROMI S.A., a device manufacturer, received an FDA Form 483 following an inspection from February 27 to March 2, 2023. The inspection revealed a significant issue with the firm's failure to submit a Medical Device Report (MDR) within 30 days of becoming aware of a device malfunction. This is a repeat observation from a previous inspection in 2017, indicating a persistent compliance problem.