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KOSE CO

⚠️ Moderate Risk

FEI: 3012569333 • TOKYO • JAPAN

FEI

FEI Number

3012569333

📍

Location

TOKYO

🇯🇵

Country

JAPAN
🏢

Address

ON 103-8251 TOKYO CENTR, , 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
8/22/2016
Latest Refusal
8/22/2016
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

4733×

LABELING

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

Refusal History

DateProductViolationsDivision
8/22/2016
53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS)
473LABELING
New Orleans District Office (NOL-DO)
8/22/2016
53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS)
473LABELING
New Orleans District Office (NOL-DO)
8/22/2016
53AD02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS)
473LABELING
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is KOSE CO's FDA import refusal history?

KOSE CO (FEI: 3012569333) has 3 FDA import refusal record(s) in our database, spanning from 8/22/2016 to 8/22/2016.

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. KOSE CO's FEI number is 3012569333.

What types of violations has KOSE CO received?

KOSE CO 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 KOSE CO come from?

All FDA import refusal data for KOSE CO 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.