DiFusion Technologies
Form 483 issued February 12, 2026 · Austin, Texas
- Inspection
- Feb 9 – Feb 12, 2026
- Investigator
- Yuliana Hernandez-Magana
- Observations
- 1
- Pages
- 3
- FEI number
- 3009336374
In short: On February 12, 2026, FDA issued a Form 483 with 1 observation to DiFusion Technologies in Austin, Texas (FEI 3009336374) after an inspection that ran Feb 9 – Feb 12, 2026. The investigator was Yuliana Hernandez-Magana. The most-cited regulation is 21 CFR 8.2.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 8.2.4
Internal audits have not been conducted at planned intervals to determine whether the QMS is…
This inspection in context
Yuliana Hernandez-Magana
4 documents · 2025–2026
Cites 820.30(e) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmDiFusion Technologies history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at DiFusion Technologies?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 8.2. The opening words of each observation are shown on this page.
Who inspected DiFusion Technologies?
Yuliana Hernandez-Magana is named on this Form 483, for the inspection of Feb 9 – Feb 12, 2026. Each investigator has a profile showing what they cite most.
When was DiFusion Technologies inspected by FDA?
The inspection ran Feb 9 – Feb 12, 2026, and the Form 483 is dated February 12, 2026.
How do I get the full Form 483 for DiFusion Technologies?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.