Company
SwedenELEKTA SOLUTIONS AB, Stockholm, Sweden – FDA Inspections
Inspection records and compliance data for ELEKTA SOLUTIONS AB in Stockholm. 1 FDA inspection on record, 1 Form 483, last inspected May 22, 2025.
Company Profile
This profile covers ELEKTA SOLUTIONS AB based in Stockholm, Sweden.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
Inspected May 22, 2025.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Individual Report of Malfunction1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 22, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1270862 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
ELEKTA SOLUTIONS AB
FEI Number
3015232217
Address
Box 7593, Haga Plan 4, Stockholm, Sweden
Country
Sweden
ID: e0d3ae85-8bab-4278-89b3-c50160ebc162