Form 483 · FEI 3002619777
Form 483 issued February 9, 2026 · Eagan, Minnesota
- Inspection
- Feb 4 – Feb 9, 2026
- Investigator
- Tyler R. Courtney
- Observations
- 4
- Pages
- 5
- FEI number
- 3002619777
In short: On February 9, 2026, FDA issued a Form 483 with 4 observations to an FDA-inspected site in Eagan, Minnesota (FEI 3002619777) after an inspection that ran Feb 4 – Feb 9, 2026. The investigator was Tyler R. Courtney.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.1
One or more processes for risk management in product realization have…
- 02ISO 13485:2016 Clause 7.3.9
Review of design and development changes did not include evaluation of the effect of the changes…
- 03
The medical device(s) label did not have a unique device identifier (UDI) present in easily readable…
- 04
The information required by the Global Unique Device Identification Database for each medical device version or…
This inspection in context
Tyler R. Courtney
4 documents · 2019–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Minnesota.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 801.40(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Tyler R. Courtney is named on this Form 483, for the inspection of Feb 4 – Feb 9, 2026. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 4 – Feb 9, 2026, and the Form 483 is dated February 9, 2026.
How do I get the full Form 483 for an FDA-inspected site?
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.