Company
SwedenScandiDos AB, Uppsala, Sweden – FDA Inspections
Inspection records and compliance data for ScandiDos AB in Uppsala. 2 FDA inspections on record, 2 Form 483s, last inspected August 28, 2019.
Company Profile
This profile covers ScandiDos AB based in Uppsala, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected July 12, 2018. Last inspected August 28, 2019.
Most cited issue areas
- Design transfer - Lack of or inadequate procedures1 inspection
- DHR - not or inadequately maintained1 inspection
- Incoming acceptance records, documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 28, 2019 | Not classified | Medical Devices & Rad Health | 1128932 |
| July 12, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1058626 |
FDA documents
Form 483s (2)
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Company Information
Name
ScandiDos AB
FEI Number
3005596716
Address
Dag Hammarskjolds Vag 52a, Uppsala, Sweden
Country
Sweden
ID: 8a121d76-151b-4e72-b3da-c6415ebaf094