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Odany-Jewa Nederland

⚠️ Moderate Risk

FEI: 3005938814 • Amsterdam Zuid-Oost • NETHERLANDS

FEI

FEI Number

3005938814

📍

Location

Amsterdam Zuid-Oost

🇳🇱
🏢

Address

Eeftink 100p, , Amsterdam Zuid-Oost, , Netherlands

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/20/2006
Latest Refusal
11/20/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

3311×

DR QUALITC

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/20/2006
62ICJ13CHLORAMBUCIL (ANTI-NEOPLASTIC)
331DR QUALITC
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Odany-Jewa Nederland's FDA import refusal history?

Odany-Jewa Nederland (FEI: 3005938814) has 1 FDA import refusal record(s) in our database, spanning from 11/20/2006 to 11/20/2006.

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. Odany-Jewa Nederland's FEI number is 3005938814.

What types of violations has Odany-Jewa Nederland received?

Odany-Jewa Nederland has been cited for 2 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 Odany-Jewa Nederland come from?

All FDA import refusal data for Odany-Jewa Nederland 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.