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ROSETTE

⚠️ Moderate Risk

FEI: 3016125824 • Tokyo • JAPAN

FEI

FEI Number

3016125824

📍

Location

Tokyo

🇯🇵

Country

JAPAN
🏢

Address

Toshinagawaku Higashish, , Tokyo, , Japan

Moderate Risk

FDA Import Risk Assessment

29.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
6/12/2023
Latest Refusal
6/12/2023
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
47.8×20%
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.

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
6/12/2023
53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
474COSMETLBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ROSETTE's FDA import refusal history?

ROSETTE (FEI: 3016125824) has 1 FDA import refusal record(s) in our database, spanning from 6/12/2023 to 6/12/2023.

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. ROSETTE's FEI number is 3016125824.

What types of violations has ROSETTE received?

ROSETTE 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 ROSETTE come from?

All FDA import refusal data for ROSETTE 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.