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

Source: https://www.keypedia.com/records/483/euromi-sa/d7f5c71f-3589-4026-89ea-bd7982f067da

> FDA 483 for EUROMI S.A. on March 02, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EUROMI S.A.
- Inspection Date: 2023-03-02
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Documents

- [WARNING_LETTER - 2015-01-15](https://www.keypedia.com/records/warning_letter/euromi-sa/0285476a-30fe-4d15-a413-18be1914319b)
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- [483 - 2023-03-02](https://www.keypedia.com/records/483/euromi-sa/af2df5c4-6ad1-40d8-9df2-db16e35c63ee)
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## Related Officers

- [Michelle L Johnson](https://www.keypedia.com/people/michelle-l-johnson/7a31a805-4066-41ec-9f65-f1f907695044)

Company: https://www.keypedia.com/companies/euromi-sa/117d63e2-e079-4816-8804-517c2fde2bf6

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4