Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-08-25.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 20 Aug 2025 – 25 Aug 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Mar 2022 – 18 Mar 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Apr 2018 – 27 Apr 2018 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Aug 2025
21 CFR 820.20(c)
Management review - defined interval, sufficient frequency
Cited by Albert L Nguyen
Investigators
FDA investigators tied to this site in the record.
Albert L Nguyen1 insp.
Ralph W Jerndal1 insp.
Yehualashe A Gessesse1 insp.
Yehualashet A Gessesse1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.200(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Dane Technologies' 3 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