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Tou-Free International Co., Ltd.

⚠️ Moderate Risk

FEI: 3003967683 • Kobe, Hyogo • JAPAN

FEI

FEI Number

3003967683

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

110-2, Ito-Cho; Chuo, Kobe, Hyogo, Japan

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
9/23/2005
Latest Refusal
9/23/2005
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4712×

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.

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).

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

DateProductViolationsDivision
9/23/2005
53BH01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
197COSM COLOR
471CSTIC LBLG
Seattle District Office (SEA-DO)
9/23/2005
53BH01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
11UNSAFE COL
471CSTIC LBLG
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Tou-Free International Co., Ltd.'s FDA import refusal history?

Tou-Free International Co., Ltd. (FEI: 3003967683) has 2 FDA import refusal record(s) in our database, spanning from 9/23/2005 to 9/23/2005.

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. Tou-Free International Co., Ltd.'s FEI number is 3003967683.

What types of violations has Tou-Free International Co., Ltd. received?

Tou-Free International Co., Ltd. has been cited for 3 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 Tou-Free International Co., Ltd. come from?

All FDA import refusal data for Tou-Free International 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.