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Dainippon Sumitomo Pharma Co Ltd

⚠️ Moderate Risk

FEI: 3005380302 • Suita, Osaka • JAPAN

FEI

FEI Number

3005380302

📍

Location

Suita, Osaka

🇯🇵

Country

JAPAN
🏢

Address

94 Enoki 33, Enoki-Cho, Suita, 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
11/19/2008
Latest Refusal
11/19/2008
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
11/19/2008
57NJ02CELL & GENE THERAPIES (HUMAN TISSUE, CELLULAR THERAPIES)
71NO LICENSE
New York District Office (NYK-DO)

Frequently Asked Questions

What is Dainippon Sumitomo Pharma Co Ltd's FDA import refusal history?

Dainippon Sumitomo Pharma Co Ltd (FEI: 3005380302) has 1 FDA import refusal record(s) in our database, spanning from 11/19/2008 to 11/19/2008.

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. Dainippon Sumitomo Pharma Co Ltd's FEI number is 3005380302.

What types of violations has Dainippon Sumitomo Pharma Co Ltd received?

Dainippon Sumitomo Pharma 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 Dainippon Sumitomo Pharma Co Ltd come from?

All FDA import refusal data for Dainippon Sumitomo Pharma 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.