Company
SwedenSvar Life Science AB, Malmo, Sweden – FDA Inspections
Inspection records and compliance data for Svar Life Science AB in Malmo. 2 FDA inspections on record (1 OAI), 1 Form 483, 1 warning letter, last inspected April 26, 2018.
Company Profile
This profile covers Svar Life Science AB based in Malmo, Sweden.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected January 19, 2017. Last inspected April 26, 2018.
Most cited issue areas
- Design review - Lack of or inadequate procedures1 inspection
- Design verification - Lack of or inadequate procedures1 inspection
- Documentation1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 26, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1055353 |
| January 19, 2017 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1000739 |
FDA documents
Form 483s (1)
Warning Letters (1)
People (4)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Svar Life Science AB
FEI Number
3007610287
Address
Box 50117, Lundavagen 151, Malmo, Sweden
Country
Sweden
ID: 7d939a93-9dfc-4058-b2bd-f4769c279603