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Hakugen Corp.

⚠️ Moderate Risk

FEI: 1000640033 • Taito, Tokyo • JAPAN

FEI

FEI Number

1000640033

📍

Location

Taito, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 214, Higashiueno, Taito, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

25.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/7/2023
Latest Refusal
2/7/2023
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
27.4×20%
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

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
2/7/2023
53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

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

Hakugen Corp. (FEI: 1000640033) has 1 FDA import refusal record(s) in our database, spanning from 2/7/2023 to 2/7/2023.

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. Hakugen Corp.'s FEI number is 1000640033.

What types of violations has Hakugen Corp. received?

Hakugen Corp. 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 Hakugen Corp. come from?

All FDA import refusal data for Hakugen Corp. 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.