Overview
- 14 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-05-19.
At a glance
Inspections
14
Form 483s
4
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 Apr 2022 – 19 May 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Aug 2021 – 9 Nov 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Jul 2017 | Medical Devices & Rad Health | Clean | |
| 21 Jan 2015 | Medical Devices & Rad Health | Clean | |
| 8 Apr 2014 – 15 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 26 Feb 2014 – 5 Mar 2014 | Medical Devices & Rad Health | Clean | |
| 3 Dec 2013 – 5 Dec 2013 | Medical Devices & Rad Health | Clean | |
| 8 Aug 2012 | Not recorded | Clean | |
| 28 Mar 2012 | Not recorded | Clean | |
| 24 Jun 2011 | Not recorded | 483 | View 483 → |
| 26 May 2010 | Not recorded | Clean | |
| 11 Dec 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
19 May 2022
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Christine I Shaw, Joshua E Yao
19 May 2022
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Christine I Shaw, Joshua E Yao
Investigators
FDA investigators tied to this site in the record.
Katelyn A Staub-Zamperini7 insp.
James M Odonnell5 insp.
Christine I Shaw1 insp.
Joshua E Yao1 insp.
MDSAP WilliamsA1 insp.
Brandon M Kurjanowicz1 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 | 4x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.10(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Philips Respironics, 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