Form 483 · FEI 3000215335
Form 483 issued February 13, 2026 · Vernon Hills, Illinois
- Inspection
- Feb 9 – Feb 13, 2026
- Investigator
- Shuana H. Xiong
- Observations
- 3
- Pages
- 5
- FEI number
- 3000215335
In short: On February 13, 2026, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Vernon Hills, Illinois (FEI 3000215335) after an inspection that ran Feb 9 – Feb 13, 2026. The investigator was Shuana H. Xiong.
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 8.5.2
Corrective action was not adequately taken to eliminate the cause of nonconformities in…
- 02ISO 13485:2016 Clause 7.1
One or more processes for risk management in product realization have…
- 03ISO 13485:2016 Clause 8.3.1
Procedures to define the controls and related responsibilities and authorities for the identification, documentation, segregation, evaluation…
This inspection in context
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Shuana H. Xiong is named on this Form 483, for the inspection of Feb 9 – Feb 13, 2026. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Feb 9 – Feb 13, 2026, and the Form 483 is dated February 13, 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.