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Mitsubishi Pencil Co Ltd

⚠️ Moderate Risk

FEI: 1000527768 • Shinagawa, Tokyo • JAPAN

FEI

FEI Number

1000527768

📍

Location

Shinagawa, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

5 Chome 23-37, Higashioi, Shinagawa, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

40.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
5/11/2023
Latest Refusal
3/21/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
31.5×20%
Frequency
30.0×10%
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

1972×

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).

4752×

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.

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
5/11/2023
53CY02EYELINER (EYE MAKEUP PREPARATIONS)
471CSTIC LBLG
Division of Southeast Imports (DSEI)
3/21/2023
53CD02EYELINER (EYE MAKEUP PREPARATIONS)
197COSM COLOR
475COSMETLBLG
Division of West Coast Imports (DWCI)
3/21/2023
53CD02EYELINER (EYE MAKEUP PREPARATIONS)
197COSM COLOR
475COSMETLBLG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Mitsubishi Pencil Co Ltd's FDA import refusal history?

Mitsubishi Pencil Co Ltd (FEI: 1000527768) has 3 FDA import refusal record(s) in our database, spanning from 3/21/2023 to 5/11/2023.

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. Mitsubishi Pencil Co Ltd's FEI number is 1000527768.

What types of violations has Mitsubishi Pencil Co Ltd received?

Mitsubishi Pencil 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 Mitsubishi Pencil Co Ltd come from?

All FDA import refusal data for Mitsubishi Pencil 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.