Overview
- 15 FDA inspections are on record.
- 12 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-11-21.
At a glance
Inspections
15
Form 483s
12
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Nov 2025 – 21 Nov 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Oct 2024 – 6 Nov 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 Oct 2023 – 3 Nov 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Oct 2022 – 27 Oct 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Aug 2021 – 20 Aug 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Feb 2020 – 25 Mar 2020 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Oct 2018 – 3 Dec 2018 | Medical Devices & Rad Health | 483 | On file |
| 18 Feb 2015 – 21 Apr 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Apr 2013 – 24 Apr 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 29 Aug 2012 | Not recorded | 483 | View 483 → |
| 9 Aug 2010 | Not recorded | 483 | View 483 → |
| 11 Apr 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Nov 2023
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Stephen R Souza, Brian R Hendricks
3 Nov 2023
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Stephen R Souza, Brian R Hendricks
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza6 insp.
Brian R Hendricks3 insp.
Paul M Kawamoto2 insp.
Cynthia L Gorveatt2 insp.
Nabil Nakhoul1 insp.
Christopher S Genther1 insp.
James R Montero1 insp.
Phillip M Pontikos1 insp.
Stanley B Eugene1 insp.
Sharon I Gundersen1 insp.
Sherri N Rohlf1 insp.
Lori J Silverstein1 insp.
Dennis G Kawabata1 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 | 8x |
| 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 820.70(i) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17(a)(3) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.50(a)(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(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.52(f)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.250(a) | 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)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a)(3) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 821.25(c) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Philips North America LLC's 12 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