Overview
- 16 FDA inspections are on record.
- 9 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-04-18.
At a glance
Inspections
16
Form 483s
9
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 15 Apr 2024 – 18 Apr 2024 | Medical Devices & Rad Health | Clean | |
| 5 Nov 2019 – 26 Nov 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 12 Mar 2019 – 29 Mar 2019 | Medical Devices & Rad Health | Clean | |
| 27 Nov 2017 – 15 Dec 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Oct 2016 – 18 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 May 2015 – 26 Jun 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Dec 2013 – 17 Jan 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Oct 2012 | Not recorded | 483 | View 483 → |
| 5 Jan 2010 | Not recorded | 483 | View 483 → |
| 30 Mar 2009 | Not recorded | 483 | View 483 → |
| 6 Feb 2008 | Not recorded | 483 | On file |
| 5 Oct 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Nov 2019
21 CFR 820.30(f)
Design verification - Lack of or inadequate procedures
Cited by Stephen R Souza, James A Lane
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza6 insp.
Paul M Kawamoto5 insp.
Cynthia L Gorveatt2 insp.
Catherine J Laufmann2 insp.
Norman Wong2 insp.
James A Lane1 insp.
James D Hildreth1 insp.
Sharon I Gundersen1 insp.
Lori J Silverstein1 insp.
Dennis G Kawabata1 insp.
Nancy A Saxenian Emmons1 insp.
Brenda L Reihing1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.52(b)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.56 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 821.25(c)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.100(a)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Physio-Control, Inc.'s 9 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