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Yumeshokunin Co LTD

✅ Low Risk

FEI: 3013252666 • Minoo, Osaka • JAPAN

FEI

FEI Number

3013252666

📍

Location

Minoo, Osaka

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 4-5 2f, Sakurai, Minoo, Osaka, Japan

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/16/2017
Latest Refusal
2/16/2017
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

Refusal History

DateProductViolationsDivision
2/16/2017
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
3260NO ENGLISH
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Yumeshokunin Co LTD's FDA import refusal history?

Yumeshokunin Co LTD (FEI: 3013252666) has 1 FDA import refusal record(s) in our database, spanning from 2/16/2017 to 2/16/2017.

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. Yumeshokunin Co LTD's FEI number is 3013252666.

What types of violations has Yumeshokunin Co LTD received?

Yumeshokunin Co LTD 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 Yumeshokunin Co LTD come from?

All FDA import refusal data for Yumeshokunin Co LTD 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.