Overview
- 15 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-06-29.
At a glance
Inspections
15
Form 483s
2
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jun 2022 – 29 Jun 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Oct 2018 – 1 Nov 2018 | Medical Devices & Rad Health | 483 | On file |
| 24 Mar 2016 – 31 Mar 2016 | Medical Devices & Rad Health | Clean | |
| 16 Jan 2014 – 30 Jan 2014 | Medical Devices & Rad Health | Clean | |
| 3 Jul 2012 | Not recorded | Clean | |
| 13 Jul 2011 | Not recorded | Clean | |
| 31 Aug 2007 | Not recorded | Clean | |
| 19 May 2005 | Not recorded | Clean | |
| 3 Feb 2005 | Not recorded | Clean | |
| 12 Sep 2003 | Not recorded | Clean | |
| 23 Apr 2002 | Not recorded | Clean | |
| 9 Mar 2001 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
29 Jun 2022
21 CFR 820.30(e)
Design review - Lack of or inadequate procedures
Cited by Ashley A Mutawakkil
29 Jun 2022
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Ashley A Mutawakkil
29 Jun 2022
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Ashley A Mutawakkil
Investigators
FDA investigators tied to this site in the record.
Dianiris C Ayala2 insp.
Ashley A Mutawakkil1 insp.
MDSAP WilliamsA1 insp.
Dawn M Mccabe1 insp.
Althea A Williams1 insp.
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 | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cordis Corporation's 2 Form 483s
Source PDFs 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