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Osteon Nv

⚠️ Moderate Risk

FEI: 3004423926 • Herent, Vlaams-Brabant • BELGIUM

FEI

FEI Number

3004423926

📍

Location

Herent, Vlaams-Brabant

🇧🇪

Country

BELGIUM
🏢

Address

Linneveld 3, , Herent, Vlaams-Brabant, Belgium

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

5
Total Refusals
1
Unique Violations
2/17/2005
Latest Refusal
2/17/2005
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

1185×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
2/17/2005
79HTFCURETTE
118NOT LISTED
New Orleans District Office (NOL-DO)
2/17/2005
87HTOREAMER
118NOT LISTED
New Orleans District Office (NOL-DO)
2/17/2005
87HWBEXTRACTOR
118NOT LISTED
New Orleans District Office (NOL-DO)
2/17/2005
76MQNEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
118NOT LISTED
New Orleans District Office (NOL-DO)
2/17/2005
79MDMINSTRUMENT, MANUAL, GENERAL SURGICAL
118NOT LISTED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Osteon Nv's FDA import refusal history?

Osteon Nv (FEI: 3004423926) has 5 FDA import refusal record(s) in our database, spanning from 2/17/2005 to 2/17/2005.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Osteon Nv's FEI number is 3004423926.

What types of violations has Osteon Nv received?

Osteon Nv has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Osteon Nv come from?

All FDA import refusal data for Osteon Nv is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.