FDA Inspection
Cortex Technology ApSCortex Technology ApS – FDA Inspection, Jun 13, 2018
Record Details
This FDA Inspection record concerns Cortex Technology ApS, with an inspection on June 13, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Lisa A. Stura (Issuing Officer)
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ID · afe877e2-b65e-4357-bb06-e3e4aca00d1f
Inspection Facts
- Inspection number
- 1056021
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
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Other FDA inspections of Cortex Technology ApS
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 9, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 31, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cortex Technology ApS
- FDA Inspection 1201255 - 2023-03-02
- FDA Inspection 929307 - 2015-06-09
- FDA Inspection 751599 - 2011-10-31
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