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Shinyo Koeki Co Ltd

✅ Low Risk

FEI: 3005281614 • Kobe, Hyogo • JAPAN

FEI

FEI Number

3005281614

📍

Location

Kobe, Hyogo

🇯🇵

Country

JAPAN
🏢

Address

79 Nihon Bldg 9f, Kyo-Machi; Chuo, Kobe, Hyogo, Japan

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
8/13/2010
Latest Refusal
8/13/2010
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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.

4731×

LABELING

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

Refusal History

DateProductViolationsDivision
8/13/2010
53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
471CSTIC LBLG
473LABELING
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Shinyo Koeki Co Ltd's FDA import refusal history?

Shinyo Koeki Co Ltd (FEI: 3005281614) has 1 FDA import refusal record(s) in our database, spanning from 8/13/2010 to 8/13/2010.

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. Shinyo Koeki Co Ltd's FEI number is 3005281614.

What types of violations has Shinyo Koeki Co Ltd received?

Shinyo Koeki Co Ltd has been cited for 2 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 Shinyo Koeki Co Ltd come from?

All FDA import refusal data for Shinyo Koeki 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.