Overview
- 5 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-01-12.
At a glance
Inspections
5
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jan 2018 – 12 Jan 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Jun 2016 – 6 Jul 2016 | Medical Devices & Rad Health | Clean | |
| 27 Apr 2015 – 8 May 2015 | Medical Devices & Rad Health | Clean | |
| 16 Dec 2013 – 18 Dec 2013 | Medical Devices & Rad Health | Clean | |
| 14 Aug 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Dustin P Tran1 insp.
Adam S Freeman1 insp.
Christopher R Czajka1 insp.
Jude C Dike1 insp.
Jeffrey W Shrifter1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.150(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cordis Corporation's 2 Form 483s
Source PDFs, verbatim observations, and 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