Overview
- 11 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2019-02-08.
At a glance
Inspections
11
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 Feb 2019 – 8 Feb 2019 | Medical Devices & Rad Health | Clean | |
| 27 Feb 2017 – 2 Mar 2017 | Medical Devices & Rad Health | Clean | |
| 24 Oct 2016 – 3 Nov 2016 | Medical Devices & Rad Health | Clean | |
| 15 Jul 2015 – 3 Aug 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Jul 2014 – 23 Jul 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jan 2013 – 7 Feb 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Jun 2010 | Not recorded | 483 | View 483 → |
| 10 Jul 2009 | Not recorded | Clean | |
| 27 Aug 2007 | Not recorded | Clean | |
| 17 Mar 2004 | Not recorded | Clean | |
| 20 Sep 2002 | 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.
Paul M Kawamoto3 insp.
Stephen R Souza2 insp.
Christopher S Genther1 insp.
MDSAP WilliamsA1 insp.
Cynthia L Gorveatt1 insp.
Xiaojun Yan1 insp.
Bryce E Mansfield1 insp.
Dennis G Kawabata1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Verathon Inc'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