Takeda Pharmaceutical Company Limited
⚠️ Moderate Risk
FEI: 3004664162 • Hikari, Yamaguchi • JAPAN
FEI Number
3004664162
Location
Hikari, Yamaguchi
Country
JAPANAddress
Takeda 4720, Mitsui, Hikari, Yamaguchi, Japan
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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).
Refusal History
Frequently Asked Questions
What is Takeda Pharmaceutical Company Limited's FDA import refusal history?
Takeda Pharmaceutical Company Limited (FEI: 3004664162) has 1 FDA import refusal record(s) in our database, spanning from 6/3/2025 to 6/3/2025.
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 Company Limited's FEI number is 3004664162.
What types of violations has Takeda Pharmaceutical Company Limited received?
Takeda Pharmaceutical Company Limited 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 Company Limited come from?
All FDA import refusal data for Takeda Pharmaceutical Company Limited 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.