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Takeda Pharmaceutical Co, Ltd

⚠️ Moderate Risk

FEI: 1000206559 • Osaka, Osaka • JAPAN

FEI

FEI Number

1000206559

📍

Location

Osaka, Osaka

🇯🇵

Country

JAPAN
🏢

Address

4 Chome 1-1, Dosho-Machi; Chuo, Osaka, Osaka, Japan

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
4/6/2012
Latest Refusal
3/10/2009
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
9.8×10%
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

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
4/6/2012
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/27/2012
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/10/2009
56FIK99PEPTIDE N.E.C.
75UNAPPROVED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Takeda Pharmaceutical Co, Ltd's FDA import refusal history?

Takeda Pharmaceutical Co, Ltd (FEI: 1000206559) has 3 FDA import refusal record(s) in our database, spanning from 3/10/2009 to 4/6/2012.

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 Pharmaceutical Co, Ltd's FEI number is 1000206559.

What types of violations has Takeda Pharmaceutical Co, Ltd received?

Takeda Pharmaceutical 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 Pharmaceutical Co, Ltd come from?

All FDA import refusal data for Takeda Pharmaceutical 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.