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Mandom Corp.

⚠️ Moderate Risk

FEI: 3002118599 • Osaka, Osaka • JAPAN

FEI

FEI Number

3002118599

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

5-12, Juniken-Cho; Chuo, Osaka, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

43.6
LowModerateHighCritical

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

Statistics

11
Total Refusals
5
Unique Violations
2/10/2025
Latest Refusal
8/30/2013
Earliest Refusal

Score Breakdown

Violation Severity
42.9×40%
Refusal Volume
40.0×30%
Recency
67.5×20%
Frequency
9.6×10%
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

47110×

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.

4753×

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.

4742×

COSMETLBLG

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

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).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
2/10/2025
53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
197COSM COLOR
471CSTIC LBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)
6/12/2023
53EG07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
474COSMETLBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)
10/31/2017
53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.
471CSTIC LBLG
Division of Southeast Imports (DSEI)
9/30/2015
53LY08PASTE MASKS (MUD PACKS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Detroit District Office (DET-DO)
9/30/2015
53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
471CSTIC LBLG
Detroit District Office (DET-DO)
9/30/2015
53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
471CSTIC LBLG
Detroit District Office (DET-DO)
1/14/2015
53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
1/2/2015
53EY07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
11/12/2014
53EY07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
4/2/2014
53EY99OTHER HAIR PREPARATIONS, NON-COLORING), N.E.C.
471CSTIC LBLG
474COSMETLBLG
475COSMETLBLG
New Orleans District Office (NOL-DO)
8/30/2013
53EG07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
473LABELING
New Orleans District Office (NOL-DO)

Frequently Asked Questions

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

Mandom Corp. (FEI: 3002118599) has 11 FDA import refusal record(s) in our database, spanning from 8/30/2013 to 2/10/2025.

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 Corp.'s FEI number is 3002118599.

What types of violations has Mandom Corp. received?

Mandom Corp. has been cited for 5 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 Corp. come from?

All FDA import refusal data for Mandom 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.