FEI 3000215335

FDA inspection history in Vernon Hills, Illinois, 2026

1
Form 483

Every document, by year

  • Form 483

2026: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2026One Form 483, at Vernon Hills, Illinois.

Cited most

Across all site observations on file

  • ISO 13485:2016 Clause 7.1
    Scope
    1
  • ISO 13485:2016 Clause 8.3.1
    1
  • ISO 13485:2016 Clause 8.5.2
    1

The complete site file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2026-02-13483 Form 483$99

Investigators on these documents

Shuana H. Xiong (1)

FEI number 3000215335 · most recent document Feb 13, 2026

About FEI 3000215335

How many FDA Form 483s has FEI 3000215335 received?

FDA Intel has 1 Form 483 on file for FEI 3000215335; the most recent is dated Feb 13, 2026.

When was FEI 3000215335 last inspected by FDA?

The most recent FDA inspection document on file for FEI 3000215335 is a Form 483 dated Feb 13, 2026, for the site in Vernon Hills, Illinois.

What did FDA cite at FEI 3000215335?

The regulations cited most in the observations on file for FEI 3000215335 are ISO 13485:2016 Clause 7.1 (Scope), 1 time; ISO 13485:2016 Clause 8.3.1, 1 time; ISO 13485:2016 Clause 8.5.2, 1 time.