Company
NorwayLaerdal Medical A/S, Stavanger, Norway – FDA Inspections
Inspection records and compliance data for Laerdal Medical A/S in Stavanger. 3 FDA inspections on record, last inspected November 10, 2016.
Company Profile
This profile covers Laerdal Medical A/S based in Stavanger, Norway.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected June 23, 2011. Last inspected November 10, 2016.
Most cited issue areas
- Investigation of device failures1 inspection
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 10, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 994026 |
| August 22, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 845097 |
| June 23, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 738432 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Laerdal Medical A/S
FEI Number
3002807435
Address
Tanke Svilandsgate 30,, Stavanger, Norway
Country
Norway
ID: 9e58f4ff-ff76-4e29-ae38-f001bf46098e