FDA Inspection
EUROMI S.A.EUROMI S.A. – FDA Inspection, Jul 31, 2025
Record Details
This FDA Inspection record concerns EUROMI S.A., with an inspection on July 31, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · b2ca4486-ce8a-45fb-bc25-1e1034f1af2c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1278218
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.18(a)Event files -- failure to establish and maintain
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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Other FDA inspections of EUROMI S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2023 | Not classified | Office of Inspections and Investigations | |
| April 21, 2017 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
| January 15, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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