Nuclein LLC
Form 483 issued January 13, 2026 · Austin, Texas
- Inspection
- Jan 5 – Jan 13, 2026
- Investigator
- Katherine M. Thames
- Observations
- 3
- Pages
- 6
- FEI number
- 3014515702
In short: On January 13, 2026, FDA issued a Form 483 with 3 observations to Nuclein LLC in Austin, Texas (FEI 3014515702) after an inspection that ran Jan 5 – Jan 13, 2026. The investigator was Katherine M. Thames. Most observations concern cAPA and design controls.
At a glance
CAPA and design controls account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Complaints involving the possible failure of a device to meet any of its specifications were…
- 02
Risk analysis is…
- 03
Sampling plans are not based…
This inspection in context
Katherine M. Thames
6 documents · 2025–2026
Cites 820.198(a) (complaint files) more than any other section. Most of their documents are for sites in Texas.
The firmNuclein LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.198(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Nuclein LLC?
FDA listed 3 observations on this Form 483, mostly about cAPA, design controls and production & process controls. The opening words of each observation are shown on this page.
Who inspected Nuclein LLC?
Katherine M. Thames is named on this Form 483, for the inspection of Jan 5 – Jan 13, 2026. Each investigator has a profile showing what they cite most.
When was Nuclein LLC inspected by FDA?
The inspection ran Jan 5 – Jan 13, 2026, and the Form 483 is dated January 13, 2026.
How do I get the full Form 483 for Nuclein LLC?
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.