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Shinonogi And Company Ltd

⚠️ Moderate Risk

FEI: 1000609485 • Osaka, Osaka • JAPAN

FEI

FEI Number

1000609485

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

3 Chome 1-8 Dosho-Machi, Chuo; Dosho-Machi; Chuo, Osaka, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/6/2007
Latest Refusal
2/6/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

711×

NO LICENSE

The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use

Refusal History

DateProductViolationsDivision
2/6/2007
57DC19NORMAL HUMAN PLASMA (BLOOD AND BLOOD DERIVATIVES)
71NO LICENSE
New York District Office (NYK-DO)

Frequently Asked Questions

What is Shinonogi And Company Ltd's FDA import refusal history?

Shinonogi And Company Ltd (FEI: 1000609485) has 1 FDA import refusal record(s) in our database, spanning from 2/6/2007 to 2/6/2007.

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. Shinonogi And Company Ltd's FEI number is 1000609485.

What types of violations has Shinonogi And Company Ltd received?

Shinonogi And 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 Shinonogi And Company Ltd come from?

All FDA import refusal data for Shinonogi And 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.