Company
DenmarkLINA Medical Aps, Glostrup, Denmark – FDA Inspections
Inspection records and compliance data for LINA Medical Aps in Glostrup. 2 FDA inspections on record, 1 Form 483, last inspected November 01, 2017.
Company Profile
This profile covers LINA Medical Aps based in Glostrup, Denmark.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 1
- Warning letters
- 0
First inspected March 22, 2011. Last inspected November 1, 2017.
Most cited issue areas
- Design input - documentation1 inspection
- Design review - Lack of or inadequate procedures1 inspection
- Design validation - user needs and intended uses1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 1, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1031380 |
| March 22, 2011 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 719043 |
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
LINA Medical Aps
FEI Number
3002626775
Address
Formervangen 5, Glostrup, Denmark
Country
Denmark
ID: 11335b35-dbc4-42fa-a051-8710f6b4de24