Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-03-02.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2023 – 2 Mar 2023 | Medical Devices & Rad Health | Clean | |
| 11 Jun 2018 – 13 Jun 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jun 2015 – 9 Jun 2015 | Medical Devices & Rad Health | Clean | |
| 31 Oct 2011 | Not recorded | 483 | On file |
| 1 Mar 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Jun 2018
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Lisa A Warner
13 Jun 2018
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Lisa A Warner
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Cortex Technology ApS' 2 Form 483s
Recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat