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

Source: https://www.keypedia.com/records/483/euromi-sa/2ab96ec0-4ff3-4d12-9623-0028dd41205b

> FDA 483 for EUROMI S.A. on July 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: EUROMI S.A.
- Inspection Date: 2025-07-31
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: 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.

## Related Documents

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- [483 - 2023-03-02](https://www.keypedia.com/records/483/euromi-sa/589dba43-fae0-4f69-ac7f-ba476978df7b)
- [483 - 2023-03-02](https://www.keypedia.com/records/483/euromi-sa/af2df5c4-6ad1-40d8-9df2-db16e35c63ee)

## Related Officers

- [Thai T. Duong](https://www.keypedia.com/people/thai-t-duong/59737092-2f30-43a7-b23b-36fa7f212c4a)

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