FDA Inspection
EUROMI S.A.EUROMI S.A. – FDA Inspection, Apr 21, 2017
Record Details
This FDA Inspection record concerns EUROMI S.A., with an inspection on April 21, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · ba62fcc8-1806-4dbf-9e65-d034c50fe7a1
Inspection Facts
- Inspection number
- 1016083
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
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Other FDA inspections of EUROMI S.A.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 31, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| March 2, 2023 | Not classified | Office of Inspections and Investigations | |
| January 15, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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