Overview
- 10 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-01-18.
At a glance
Inspections
10
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Jan 2024 – 18 Jan 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Nov 2022 – 21 Nov 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Dec 2019 – 18 Dec 2019 | Medical Devices & Rad Health | Clean | |
| 13 Dec 2016 – 14 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 11 Dec 2014 – 12 Dec 2014 | Medical Devices & Rad Health | Clean | |
| 20 Nov 2012 | Not recorded | Clean | |
| 3 Aug 2010 | Not recorded | Clean | |
| 24 Sep 2008 | Not recorded | Clean | |
| 19 May 2006 | Not recorded | Clean | |
| 10 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Jan 2024
21 CFR 806.20(b)(4)
Justification for not reporting
Cited by Stephen R Souza, Brian R Hendricks
18 Jan 2024
21 CFR 806.20(b)(4)
Justification for not reporting
Cited by Stephen R Souza, Brian R Hendricks
18 Jan 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Stephen R Souza, Brian R Hendricks
18 Jan 2024
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Stephen R Souza, Brian R Hendricks
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza1 insp.
Brian R Hendricks1 insp.
Christopher S Genther1 insp.
James A Lane1 insp.
Paul M Kawamoto1 insp.
Cynthia L Gorveatt1 insp.
Sharon I Gundersen1 insp.
Xiaojun Yan1 insp.
Lori J Silverstein1 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 | 3x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(a) | 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 Fluke Biomedical LLC's 2 Form 483s
Source PDFs 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