Company
SwedenMIRIS AB, Uppsala, Sweden – FDA Inspections
Inspection records and compliance data for MIRIS AB in Uppsala. 2 FDA inspections on record, 1 Form 483, last inspected August 20, 2026.
Company Profile
This profile covers MIRIS AB based in Uppsala, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 15, 2024. Last inspected August 20, 2026.
Most cited issue areas
- Design and development validation not complete prior to release of product1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 20, 2026 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1331748 |
| February 15, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1233654 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
MIRIS AB
FEI Number
3013887826
Address
Danmarksgatan 26, Uppsala, Sweden
Country
Sweden
ID: ee59579b-54ba-4e6b-bb84-afb3df488566