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Cosmetex Roland Co.,Ltd.

⚠️ Moderate Risk

FEI: 3011444902 • Minato, Tokyo • JAPAN

FEI

FEI Number

3011444902

📍

Location

Minato, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

1 Chome 12-32, Akasaka, Minato, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/23/2011
Latest Refusal
8/23/2011
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
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

4713×

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
8/23/2011
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
San Francisco District Office (SAN-DO)
8/23/2011
53KC01AFTERSHAVE LOTION (SHAVING PREPARATIONS)
471CSTIC LBLG
San Francisco District Office (SAN-DO)
8/23/2011
53LH03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
San Francisco District Office (SAN-DO)

Frequently Asked Questions

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

Cosmetex Roland Co.,Ltd. (FEI: 3011444902) has 3 FDA import refusal record(s) in our database, spanning from 8/23/2011 to 8/23/2011.

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. Cosmetex Roland Co.,Ltd.'s FEI number is 3011444902.

What types of violations has Cosmetex Roland Co.,Ltd. received?

Cosmetex Roland 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 Cosmetex Roland Co.,Ltd. come from?

All FDA import refusal data for Cosmetex Roland 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.