Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-01-31.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 13 Jan 2025 – 31 Jan 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 Nov 2021 – 10 Nov 2021 | Medical Devices & Rad Health | Clean | |
| 14 Aug 2017 – 17 Aug 2017 | Medical Devices & Rad Health | 483 | On file |
| 1 Aug 2016 – 5 Aug 2016 | Medical Devices & Rad Health | 483 | On file |
| 3 Aug 2015 – 7 Aug 2015 | Medical Devices & Rad Health | 483 | On file |
| 9 Dec 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
31 Jan 2025
21 CFR 820.100(a)
Lack of or inadequate procedures
31 Jan 2025
21 CFR 820.198(d)
Evaluation, timeliness, identification
31 Jan 2025
21 CFR 820.50
Purchasing controls, Lack of or inadequate procedures
31 Jan 2025
21 CFR 820.80(b)
Lack of or inadequate receiving acceptance procedures
Investigators
FDA investigators tied to this site in the record.
MDSAP harperd2 insp.
Katelyn A Staub-Zamperini1 insp.
Marlo-Ian M Alintanahin1 insp.
Christopher S Genther1 insp.
MDSAP WilliamsA1 insp.
MSDAP GonzlezK1 insp.
Graham N Giesen1 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 | 2x |
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Philips Ultrasound, LLC'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