Overview
- 2 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-02-12.
At a glance
Inspections
2
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 12 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jul 2023 – 26 Jul 2023 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Feb 2026
ISO 13485:2016 Clause 8.2.4
Internal audits not conducted to ensure QMS meets requirements and is effective
Cited by Yuliana Hernandez-Magana
Investigators
FDA investigators tied to this site in the record.
Yuliana Hernandez-Magana1 insp.
State Agency1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DiFusion Technologies' 1 Form 483
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