Overview
- 11 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2018-08-13.
At a glance
Inspections
11
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 7 Aug 2018 – 13 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Jun 2017 – 27 Jun 2017 | Medical Devices & Rad Health | Clean | |
| 15 Jun 2016 – 27 Jul 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Aug 2014 – 10 Sep 2014 | Medical Devices & Rad Health | WL | View 483 → |
| 7 Feb 2012 | Not recorded | 483 | View 483 → |
| 9 Jun 2009 | Not recorded | Clean | |
| 8 Oct 2008 | Not recorded | 483 | View 483 → |
| 20 Apr 2007 | Not recorded | Clean | |
| 6 Oct 2005 | Not recorded | Clean | |
| 5 Aug 2004 | Not recorded | Clean | |
| 14 Aug 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
27 Jul 2016
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Cynthia L Gorveatt, Sharon I Gundersen
27 Jul 2016
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Cynthia L Gorveatt, Sharon I Gundersen
27 Jul 2016
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Cynthia L Gorveatt, Sharon I Gundersen
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza3 insp.
Cynthia L Gorveatt2 insp.
Sharon I Gundersen2 insp.
Christopher S Genther1 insp.
Paul M Kawamoto1 insp.
Lori J Silverstein1 insp.
Dennis G Kawabata1 insp.
Catherine J Laufmann1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Natus Medical Incorporated's 5 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