Biomat USA Inc
Form 483 issued April 14, 2026 · Lufkin, Texas
- Inspection
- Apr 8 – Apr 14, 2026
- Investigator
- Elyshia Q. Danaher
- Observations
- 3
- Pages
- 5
- FEI number
- 3014028128
In short: On April 14, 2026, FDA issued a Form 483 with 3 observations to Biomat USA Inc in Lufkin, Texas (FEI 3014028128) after an inspection that ran Apr 8 – Apr 14, 2026. The investigator was Elyshia Q. Danaher. Most observations concern biologics CGMP.
At a glance
3 of 3 observations on this 483 concern biologics cgmp.
What FDA observed
Preview: the opening words of each observation- 01
Failure to present educational material to the donor in an appropriate form and in a manner…
- 02
Failure to perform a thorough investigation and make a record of the conclusions and follow-up…
- 03
Failure to maintain donor…
This inspection in context
Elyshia Q. Danaher
3 documents · 2025–2026
Cites 1271.55 (what records must accompany an hct/p after the donor-eligibility determination is complete; and what records must i retain?) more than any other section. Most of their documents are for sites in Texas.
The firmBiomat USA Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 630.10(b)
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 opening words of each observation are shown on this page.
Who inspected Biomat USA Inc?
Elyshia Q. Danaher is named on this Form 483, for the inspection of Apr 8 – Apr 14, 2026. Each investigator has a profile showing what they cite most.
When was Biomat USA Inc inspected by FDA?
The inspection ran Apr 8 – Apr 14, 2026, and the Form 483 is dated April 14, 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.