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OXYGEN DEVELOPMENT EUROPE POLAND

⚠️ Moderate Risk

FEI: 3015203058 • Walbrzych, Dolnoslaskie • POLAND

FEI

FEI Number

3015203058

📍

Location

Walbrzych, Dolnoslaskie

🇵🇱

Country

POLAND
🏢

Address

Ul. Ludowa 61b, , Walbrzych, Dolnoslaskie, Poland

Moderate Risk

FDA Import Risk Assessment

46.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/18/2022
Latest Refusal
4/18/2022
Earliest Refusal

Score Breakdown

Violation Severity
100.0×40%
Refusal Volume
11.2×30%
Recency
11.3×20%
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

3101×

POISONOUS

The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.

Refusal History

DateProductViolationsDivision
4/18/2022
53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS)
310POISONOUS
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is OXYGEN DEVELOPMENT EUROPE POLAND's FDA import refusal history?

OXYGEN DEVELOPMENT EUROPE POLAND (FEI: 3015203058) has 1 FDA import refusal record(s) in our database, spanning from 4/18/2022 to 4/18/2022.

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. OXYGEN DEVELOPMENT EUROPE POLAND's FEI number is 3015203058.

What types of violations has OXYGEN DEVELOPMENT EUROPE POLAND received?

OXYGEN DEVELOPMENT EUROPE POLAND 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 OXYGEN DEVELOPMENT EUROPE POLAND come from?

All FDA import refusal data for OXYGEN DEVELOPMENT EUROPE POLAND 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.