FDA Inspection
MIRIS ABMIRIS AB – FDA Inspection, Aug 20, 2026
Record Details
This FDA Inspection record concerns MIRIS AB, with an inspection on August 20, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · eca1526e-d180-449f-9a05-66adb3f8c6e5
Inspection Facts
- Inspection number
- 1331748
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MIRIS AB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 15, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MIRIS AB
- FDA Inspection 1233654 - 2024-02-15
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