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Toyo Hakko Co., Ltd.

⚠️ Moderate Risk

FEI: 3005199267 • Obu, Aichi • JAPAN

FEI

FEI Number

3005199267

📍

Location

Obu, Aichi

🇯🇵

Country

JAPAN
🏢

Address

39, Yoshikawa-Machi, Obu, Aichi, Japan

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
7/20/2006
Latest Refusal
7/20/2006
Earliest Refusal

Score Breakdown

Violation Severity
52.5×40%
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

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

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.

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
7/20/2006
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
11UNSAFE COL
471CSTIC LBLG
474COSMETLBLG
475COSMETLBLG
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Toyo Hakko Co., Ltd.'s FDA import refusal history?

Toyo Hakko Co., Ltd. (FEI: 3005199267) has 1 FDA import refusal record(s) in our database, spanning from 7/20/2006 to 7/20/2006.

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. Toyo Hakko Co., Ltd.'s FEI number is 3005199267.

What types of violations has Toyo Hakko Co., Ltd. received?

Toyo Hakko Co., Ltd. has been cited for 4 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 Toyo Hakko Co., Ltd. come from?

All FDA import refusal data for Toyo Hakko 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.