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YUZUKI CO LTD LIMITED

Low Risk

FEI: 3014641439 • Kato-Gun, Hokkaido • JAPAN

FEI

FEI Number

3014641439

📍

Location

Kato-Gun, Hokkaido

🇯🇵

Country

JAPAN
🏢

Address

West 18-2 9th, Azashimootofuke; Otofuke-Cho, Kato-Gun, Hokkaido, Japan

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
6/27/2019
Latest Refusal
6/27/2019
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3241×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

Refusal History

DateProductViolationsDivision
6/27/2019
33EGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
324NO ENGLISH
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is YUZUKI CO LTD LIMITED's FDA import refusal history?

YUZUKI CO LTD LIMITED (FEI: 3014641439) has 1 FDA import refusal record(s) in our database, spanning from 6/27/2019 to 6/27/2019.

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. YUZUKI CO LTD LIMITED's FEI number is 3014641439.

What types of violations has YUZUKI CO LTD LIMITED received?

YUZUKI CO LTD LIMITED 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 YUZUKI CO LTD LIMITED come from?

All FDA import refusal data for YUZUKI CO LTD LIMITED 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.