Overview
- 9 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2022-12-14.
At a glance
Inspections
9
Form 483s
1
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Dec 2022 – 14 Dec 2022 | Medical Devices & Rad Health | Clean | |
| 29 Aug 2016 – 1 Sep 2016 | Medical Devices & Rad Health | Clean | |
| 16 Sep 2015 – 25 Sep 2015 | Medical Devices & Rad Health | Clean | |
| 20 Oct 2014 – 24 Oct 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Dec 2012 | Not recorded | Clean | |
| 27 Sep 2012 | Not recorded | Clean | |
| 5 Aug 2010 | Not recorded | Clean | |
| 9 Feb 2006 | Not recorded | Clean | |
| 22 Sep 2004 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Oct 2014
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
Cited by Susan M Matthias
Investigators
FDA investigators tied to this site in the record.
Joseph D Gong1 insp.
Kyle J Mccracken1 insp.
Yehualashe A Gessesse1 insp.
Susan M Matthias1 insp.
Sharon L Matson1 insp.
Benjamin W Anderson1 insp.
Jaclyn N Munsch1 insp.
James A Beaulieu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Cardiovascular Systems Inc's 1 Form 483
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