FDA Inspection
EUROMI S.A.EUROMI S.A. – FDA Inspection, Jan 15, 2015
Record Details
This FDA Inspection record concerns EUROMI S.A., with an inspection on January 15, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- EUROMI S.A.
- Inspection Date
- January 15, 2015
- Product Type
- Devices
View Company Profile
ID · a1269fe5-8d65-44ff-ba72-77c67c0559e4
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 914498
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.120Lack of or inadequate procedures for labeling
Showing 10 of 14 citations.
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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 | |
| April 21, 2017 | Not classified | Office of Inspections and Investigations | Postmarket Assurance: Devices |
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