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MAKE WEBO AB

⚠️ Moderate Risk

FEI: 3014914513 • Lidkoping, Vastra Gotalands Lan • SWEDEN

FEI

FEI Number

3014914513

📍

Location

Lidkoping, Vastra Gotalands Lan

🇸🇪

Country

SWEDEN
🏢

Address

Skaragatan 75, , Lidkoping, Vastra Gotalands Lan, Sweden

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
1
Unique Violations
12/13/2013
Latest Refusal
12/13/2013
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

37811×

TPNOWRNLBL

This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is a tobacco product which appears to be misbranded under section 903(a)(8)(B)(i) and 903(a)(1) because its package label does not include a brief statement of the relevant warnings (i.e., one of the four warnings required by section 3 of the Comprehensive Smokeless Tobacco Health Education Act).

Refusal History

DateProductViolationsDivision
12/13/2013
98C06SNUS
3781TPNOWRNLBL
Philadelphia District Office (PHI-DO)

Frequently Asked Questions

What is MAKE WEBO AB's FDA import refusal history?

MAKE WEBO AB (FEI: 3014914513) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2013 to 12/13/2013.

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. MAKE WEBO AB's FEI number is 3014914513.

What types of violations has MAKE WEBO AB received?

MAKE WEBO AB 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 MAKE WEBO AB come from?

All FDA import refusal data for MAKE WEBO AB 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.