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Mandom Co., Ltd.

✅ Low Risk

FEI: 1000441235 • Osaka, Osaka • JAPAN

FEI

FEI Number

1000441235

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 37, Higashimikuni; Yodogawa, Osaka, 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
1
Unique Violations
5/24/2013
Latest Refusal
5/24/2013
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

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
5/24/2013
53FY01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI
471CSTIC LBLG
New Orleans District Office (NOL-DO)

Frequently Asked Questions

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

Mandom Co., Ltd. (FEI: 1000441235) has 1 FDA import refusal record(s) in our database, spanning from 5/24/2013 to 5/24/2013.

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. Mandom Co., Ltd.'s FEI number is 1000441235.

What types of violations has Mandom Co., Ltd. received?

Mandom Co., Ltd. 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 Mandom Co., Ltd. come from?

All FDA import refusal data for Mandom 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.