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K.K. Hakugen

✅ Low Risk

FEI: 3000291935 • Japan • JAPAN

FEI

FEI Number

3000291935

📍

Location

Japan

🇯🇵

Country

JAPAN
🏢

Address

2-21-14 Higashi Ueno, , Taito-Ku 110 Tokyo, Japan, , Japan

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/4/2007
Latest Refusal
10/4/2007
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

32603×

NO ENGLISH

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

3413×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
10/4/2007
80LDQDEVICE, GENERAL MEDICAL
3260NO ENGLISH
341REGISTERED
Los Angeles District Office (LOS-DO)
10/4/2007
80LDQDEVICE, GENERAL MEDICAL
3260NO ENGLISH
341REGISTERED
Los Angeles District Office (LOS-DO)
10/4/2007
80LDQDEVICE, GENERAL MEDICAL
3260NO ENGLISH
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is K.K. Hakugen's FDA import refusal history?

K.K. Hakugen (FEI: 3000291935) has 3 FDA import refusal record(s) in our database, spanning from 10/4/2007 to 10/4/2007.

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. K.K. Hakugen's FEI number is 3000291935.

What types of violations has K.K. Hakugen received?

K.K. Hakugen 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 K.K. Hakugen come from?

All FDA import refusal data for K.K. Hakugen 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.