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Nevion Manufacturing Sp. Z O.O.

⚠️ Moderate Risk

FEI: 3009601920 • Gdansk, Pomorskie • POLAND

FEI

FEI Number

3009601920

📍

Location

Gdansk, Pomorskie

🇵🇱

Country

POLAND
🏢

Address

Ul. Trakt Sw. Wojciecha 237, , Gdansk, Pomorskie, Poland

Moderate Risk

FDA Import Risk Assessment

42.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/28/2024
Latest Refusal
8/28/2024
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
72.2×20%
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

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
8/28/2024
95RFNFIBER OPTIC COMMUNICATION AND DATA TRANSFER, LASER
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Nevion Manufacturing Sp. Z O.O.'s FDA import refusal history?

Nevion Manufacturing Sp. Z O.O. (FEI: 3009601920) has 1 FDA import refusal record(s) in our database, spanning from 8/28/2024 to 8/28/2024.

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. Nevion Manufacturing Sp. Z O.O.'s FEI number is 3009601920.

What types of violations has Nevion Manufacturing Sp. Z O.O. received?

Nevion Manufacturing Sp. Z O.O. 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 Nevion Manufacturing Sp. Z O.O. come from?

All FDA import refusal data for Nevion Manufacturing Sp. Z O.O. 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.