Company
SwedenM Dialysis AB, Stockholm, Sweden – FDA Inspections
Inspection records and compliance data for M Dialysis AB in Stockholm. 2 FDA inspections on record, 1 Form 483, last inspected November 09, 2017.
Company Profile
This profile covers M Dialysis AB based in Stockholm, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected March 13, 2014. Last inspected November 9, 2017.
Most cited issue areas
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Nonconforming product control1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2017 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1031381 |
| March 13, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 872452 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
M Dialysis AB
FEI Number
3003733874
Address
Hammarby Fabriksvag 43, Stockholm, Sweden
Country
Sweden
ID: 4ee607fe-edbe-45c6-b325-452c8f8dded7