EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles
Form 483 issued March 2, 2023 · Andrimont, Belgium
- Inspection
- Feb 27 – Mar 2, 2023
- Investigator
- Michelle L. Johnson
- Observations
- 1
- Pages
- 3
- FEI number
- 3007697975
In short: On March 2, 2023, FDA issued a Form 483 with 1 observation to EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles in Andrimont, Belgium (FEI 3007697975) after an inspection that ran Feb 27 – Mar 2, 2023. The investigator was Michelle L. Johnson. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Michelle L. Johnson
2 documents · 2019–2023
Cites 803.50 (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Belgium.
The firmEUROMI 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 483sOther sites cited under 803.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected EUROMI S.A. ZI des Plenesses, Rue Des Nouvelles?
Michelle L. Johnson is named on this Form 483, for the inspection of Feb 27 – Mar 2, 2023. 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 Feb 27 – Mar 2, 2023, 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.