EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles

Form 483 issued March 2, 2023

Inspection: Jul 28 – Jul 31, 2025
Investigator: Thai Duong
Observations: 5
Pages: 5
FEI number: 3007697975

In short: On March 2, 2023, FDA issued a Form 483 with 5 observations to EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles (FEI 3007697975) after an inspection that ran Jul 28 – Jul 31, 2025. The investigator was Thai Duong. Most observations concern cAPA and production & process controls.

At a glance

CAPA and production & process controls account for 4 of 5 observations.

CAPA2

Production & process controls2

Other1

What FDA observed

Preview: the opening words of each observation

01
21 CFR 820.100(a)
Procedures for corrective and preventive action have…
02
21 CFR 820.80(a)
Procedures for acceptance activities…
03
21 CFR 820.70(a)
Process control procedures that describe any process controls necessary to ensure conformance to specifications have…
04
21 CFR 803.18(a)
MDR event files have not…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

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This inspection in context

The investigator

Thai Duong

5 documents · 2001–2025

Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.

The firm

EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles history

All 4 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.100(a)

See how FDA wrote the same problem up elsewhere.

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483
Form 483 from this inspectionJul 31, 2025$99

EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles site file

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Questions about this 483

What did FDA find at EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles?

FDA listed 5 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.

Who inspected EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles?

Thai Duong is named on this Form 483, for the inspection of Jul 28 – Jul 31, 2025. Each investigator has a profile showing what they cite most.

When was EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles inspected by FDA?

The inspection ran Jul 28 – Jul 31, 2025, and the Form 483 is dated March 2, 2023.

How do I get the full Form 483 for EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles?

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.