Company
NorwayNordicNeuroLab AS, Bergen, Norway – FDA Inspections
Inspection records and compliance data for NordicNeuroLab AS in Bergen. 3 FDA inspections on record, 2 Form 483s, last inspected November 09, 2018.
Company Profile
This profile covers NordicNeuroLab AS based in Bergen, Norway.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected September 13, 2012. Last inspected November 9, 2018.
Most cited issue areas
- Design changes - Lack of or Inadequate Procedures1 inspection
- Domestic & foreign consignees1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 9, 2018 | Not classified | Medical Devices & Rad Health | 1105802 |
| June 15, 2017 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1016002 |
| September 13, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 798168 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
NordicNeuroLab AS
FEI Number
3006738448
Address
Mollendalsveien 65c, Bergen, Norway
Country
Norway
ID: d023d59b-184e-44cf-a5c4-60eae2fc805c