Company
DenmarkCortex Technology ApS, Aalborg Ost, Denmark – FDA Inspections
Inspection records and compliance data for Cortex Technology ApS in Aalborg Ost. 4 FDA inspections on record, 1 Form 483, last inspected March 02, 2023.
Company Profile
This profile covers Cortex Technology ApS based in Aalborg Ost, Denmark.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 31, 2011. Last inspected March 2, 2023.
Most cited issue areas
- Design input - documentation1 inspection
- Design validation- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 2, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1201255 |
| June 13, 2018 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1056021 |
| June 9, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 929307 |
| October 31, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 751599 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Cortex Technology ApS
FEI Number
3002987034
Address
Niels Jernes Vej 6b, Aalborg Ost, Denmark
Country
Denmark
ID: 1e0445c1-c3e7-49e7-aeac-cf1dc025e3df