FDA Inspection
Anteis SaAnteis Sa – FDA Inspection, Feb 25, 2026
Record Details
This FDA Inspection record concerns Anteis Sa, with an inspection on February 25, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 4e816ed8-0ebe-45cb-8694-9477191d3c8b
Inspection Facts
- Inspection number
- 1305880
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
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Other FDA inspections of Anteis Sa
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 4, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Anteis Sa
- FDA Inspection 823159 - 2013-02-15
- FDA Inspection 630082 - 2009-11-04
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