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Takeda Yakuhin Kogyo Co Ltd

⚠️ Moderate Risk

FEI: 3003913982 • Chuo, Tokyo • JAPAN

FEI

FEI Number

3003913982

📍

Location

Chuo, Tokyo

🇯🇵

Country

JAPAN
🏢

Address

2 Chome 12-10, Nipponbashi, Chuo, Tokyo, Japan

Moderate Risk

FDA Import Risk Assessment

39.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
11/15/2012
Latest Refusal
5/19/2011
Earliest Refusal

Score Breakdown

Violation Severity
77.5×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
20.1×10%
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

113×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2741×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

Refusal History

DateProductViolationsDivision
11/15/2012
29YBT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
274COLOR LBLG
Chicago District Office (CHI-DO)
11/15/2012
33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Chicago District Office (CHI-DO)
5/19/2011
29YGT99SOFT DRINKS AND WATERS NOT MENTIONED ELSEWHERE, N.E.C.
11UNSAFE COL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Takeda Yakuhin Kogyo Co Ltd's FDA import refusal history?

Takeda Yakuhin Kogyo Co Ltd (FEI: 3003913982) has 3 FDA import refusal record(s) in our database, spanning from 5/19/2011 to 11/15/2012.

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. Takeda Yakuhin Kogyo Co Ltd's FEI number is 3003913982.

What types of violations has Takeda Yakuhin Kogyo Co Ltd received?

Takeda Yakuhin Kogyo 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 Takeda Yakuhin Kogyo Co Ltd come from?

All FDA import refusal data for Takeda Yakuhin Kogyo 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.