EUROMI S.A.March 2, 2023

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

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Record Details

An FDA inspection of EUROMI S.A. in Andrimont, Belgium, identified a significant compliance issue related to medical device reporting. The firm failed to submit a Medical Device Report (MDR) within 30 days of becoming aware of a device malfunction, which is a repeat observation from a previous inspection. This indicates a persistent problem with timely reporting of potentially serious device issues.

Company: EUROMI S.A.
Inspection Date: March 2, 2023
Product Type: Device
Office: Office of Medical Device and Radiological Health Operations
Person: Michelle L Johnson

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ID · d7f5c71f-3589-4026-89ea-bd7982f067da