Overview
- 10 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2016-10-27.
At a glance
Inspections
10
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Oct 2016 – 27 Oct 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Feb 2016 – 12 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Nov 2014 – 20 Nov 2014 | Medical Devices & Rad Health | 483 | On file |
| 12 May 2014 – 15 May 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Mar 2013 – 22 Mar 2013 | Medical Devices & Rad Health | Clean | |
| 28 Jun 2012 | Not recorded | Clean | |
| 26 May 2011 | Not recorded | Clean | |
| 10 Dec 2009 | Not recorded | Clean | |
| 18 Sep 2008 | Not recorded | Clean | |
| 24 Aug 2007 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Oct 2016
21 CFR 211.170(b)
Reserve drug product sample quantity - all tests
Cited by Kimberly Lewandowski-Walker
27 Oct 2016
21 CFR 211.170(b)
Reserve drug product sample quantity - all tests
Cited by Kimberly Lewandowski-Walker
27 Oct 2016
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Kimberly Lewandowski-Walker
27 Oct 2016
21 CFR 211.84(d)(2)
Establish reliability of supplier's C of A
Cited by Kimberly Lewandowski-Walker
12 Feb 2016
21 CFR 211.160(a)
Deviations from laboratory control requirements
Cited by Gregson A Joseph, Arie Menachem
Investigators
FDA investigators tied to this site in the record.
Kimberly Lewandowski-Walker2 insp.
Gregson A Joseph1 insp.
Arie Menachem1 insp.
Roy Baby1 insp.
David H Smith1 insp.
Erin L Mcfiren1 insp.
Tania E Vizcaino1 insp.
Eric S Pittman1 insp.
James D Planchon1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.170(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.160(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Medtronic Vascular Galway DBA Medtronic Ireland's 4 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