Biomat USA Inc
Form 483 issued February 4, 2026 · Surprise, Arizona
- Inspection
- Jan 27 – Feb 4, 2026
- Investigator
- Emily S. McGann
- Observations
- 3
- Pages
- 4
- FEI number
- 3024304918
In short: On February 4, 2026, FDA issued a Form 483 with 3 observations to Biomat USA Inc in Surprise, Arizona (FEI 3024304918) after an inspection that ran Jan 27 – Feb 4, 2026. The investigator was Emily S. McGann. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.100 (standard operating procedures).
At a glance
3 of 3 observations on this 483 concern biologics cgmp.
What FDA observed
Preview: the opening words of each observation- 01
Records fail to show test results so as to provide a complete histoiy…
- 02
Written standard operating procedures including all steps to be followed in the collection of blood and…
- 03
The standard operating procedure fails to include a written description of the procedures for investigating adverse…
This inspection in context
Emily S. McGann
6 documents · 2024–2026
Cites 1271.50 (how do i determine whether a donor is eligible?) more than any other section. Most of their documents are for sites in Arizona.
The firmBiomat USA Inc history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 606.160(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Biomat USA Inc?
FDA listed 3 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.100 (standard operating procedures). The opening words of each observation are shown on this page.
Who inspected Biomat USA Inc?
Emily S. McGann is named on this Form 483, for the inspection of Jan 27 – Feb 4, 2026. Each investigator has a profile showing what they cite most.
When was Biomat USA Inc inspected by FDA?
The inspection ran Jan 27 – Feb 4, 2026, and the Form 483 is dated February 4, 2026.
How do I get the full Form 483 for Biomat USA Inc?
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.