Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-05-21.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 May 2026 – 21 May 2026 | Medical Devices & Rad Health | Clean | |
| 14 Jan 2019 – 17 Jan 2019 | Medical Devices & Rad Health | Clean | |
| 27 Feb 2017 – 2 Mar 2017 | Medical Devices & Rad Health | Clean | |
| 14 Sep 2015 – 17 Sep 2015 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Sep 2015
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Michelle J Glembin
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 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind CORTRONIK GmbH's 1 Form 483
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