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•Belgium

EUROMI S.A., Dison, Belgium – FDA Inspections

Inspection records and compliance data for EUROMI S.A. in Dison. 4 FDA inspections on record (1 OAI), 3 Form 483s, 1 warning letter, last inspected July 31, 2025.

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Company Profile

This profile covers EUROMI S.A. based in Dison, Belgium.

FDA Inspection History

FDA inspections
4
OAI
1
VAI
1
NAI
0
Unclassified
2
Form 483s
3
Warning letters
1

First inspected January 15, 2015. Last inspected July 31, 2025.

Most cited issue areas

  • Lack of or inadequate procedures3 inspections
  • Calibration, Inspection, etc. Procedures Lack of or Inadequ2 inspections
  • Individual Report of Malfunction2 inspections

FDA inspections (4)

DateResultFDA center(s)Insp. #
July 31, 2025VAIMedical Devices & Rad Health · Compliance: Medical Devices1278218
March 2, 2023Not classifiedMedical Devices & Rad Health1198642
April 21, 2017Not classifiedMedical Devices & Rad Health · Postmarket Assurance: Devices1016083
January 15, 2015OAIMedical Devices & Rad Health · Compliance: Devices914498
FDA documents

Form 483s (2)

  • Form 483s · July 31, 2025
  • Form 483s · March 2, 2023

Warning Letters (1)

  • Warning Letters · January 15, 2015
People (4)
Jan B. Welch
Person
Michelle L. Johnson
Person
Michelle L Johnson
Person
Thai T. Duong
Person
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Company Information

Name

EUROMI S.A.

FEI Number

3007697975

Address

Zi Des Plenesses, Rue Des Nouvelles Technologies 11, Dison, Belgium

Country

Belgium

ID: 117d63e2-e079-4816-8804-517c2fde2bf6

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