ImportRefusal LogoImportRefusal

Japan Vilene Company Ltd

⚠️ Moderate Risk

FEI: 3009453411 • Chuo, Tokyo • JAPAN

FEI

FEI Number

3009453411

📍

Location

Chuo, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

, Tsukiji 5-Chome Chuo-Ku, 6-4; Tsukiji, Chuo, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/21/2013
Latest Refusal
10/21/2013
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

DateProductViolationsDivision
10/21/2013
66YSY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
72NEW VET DR
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Japan Vilene Company Ltd's FDA import refusal history?

Japan Vilene Company Ltd (FEI: 3009453411) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2013 to 10/21/2013.

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. Japan Vilene Company Ltd's FEI number is 3009453411.

What types of violations has Japan Vilene Company Ltd received?

Japan Vilene Company 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 Japan Vilene Company Ltd come from?

All FDA import refusal data for Japan Vilene Company 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.