FDA Intel

FEI 3002619777

FDA inspection history in Eagan, Minnesota, 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 Eagan, Minnesota.

Cited most

Across all site observations on file

  • ISO 13485:2016 Clause 7.1
    Scope
    1
  • ISO 13485:2016 Clause 7.3.9
    Definitions
    1
  • 21 CFR 801.40(a)
    Form of a unique device identifier
    1
  • 21 CFR 830.300(a)
    Devices subject to device identification data submission requirements
    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
2026-02-09483 Form 483$99

Investigators on these documents

Tyler R. Courtney (1)

FEI number 3002619777 · most recent document Feb 9, 2026

About FEI 3002619777

How many FDA Form 483s has FEI 3002619777 received?

FDA Intel has 1 Form 483 on file for FEI 3002619777; the most recent is dated Feb 9, 2026.

When was FEI 3002619777 last inspected by FDA?

The most recent FDA inspection document on file for FEI 3002619777 is a Form 483 dated Feb 9, 2026, for the site in Eagan, Minnesota.

What did FDA cite at FEI 3002619777?

The regulations cited most in the observations on file for FEI 3002619777 are ISO 13485:2016 Clause 7.1 (Scope), 1 time; ISO 13485:2016 Clause 7.3.9 (Definitions), 1 time; 21 CFR 801.40(a) (Form of a unique device identifier), 1 time.