Overview
- 12 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-07-11.
At a glance
Inspections
12
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Jul 2019 – 11 Jul 2019 | Medical Devices & Rad Health | Clean | |
| 28 Aug 2017 – 31 Aug 2017 | Medical Devices & Rad Health | Clean | |
| 3 Nov 2014 – 7 Nov 2014 | Medical Devices & Rad Health | Clean | |
| 12 Nov 2013 – 14 Nov 2013 | Medical Devices & Rad Health | Clean | |
| 19 Feb 2013 – 22 Feb 2013 | Medical Devices & Rad Health | Clean | |
| 13 Jan 2012 | Not recorded | Clean | |
| 10 Nov 2010 | Not recorded | 483 | View 483 → |
| 20 Nov 2009 | Not recorded | 483 | View 483 → |
| 9 Oct 2008 | Not recorded | 483 | On file |
| 30 Jun 2008 | Not recorded | 483 | On file |
| 2 Aug 2006 | Not recorded | Clean | |
| 14 Sep 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jude C Dike2 insp.
Paul M Kawamoto1 insp.
Sheri S Oliver1 insp.
Joseph A Seitz1 insp.
Maida Henesian1 insp.
Sandra S Saniga1 insp.
Timothy C Grome1 insp.
Lance M De Souza1 insp.
Marie K Kinkade1 insp.
Sergio Chavez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 812.46(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic Vascular, Inc.'s 4 Form 483s
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