Takeda Pharmaceutical Company Limited
⚠️ Moderate Risk
FEI: 3002808311 • Yodogawa-Ku, Osaka • JAPAN
FEI Number
3002808311
Location
Yodogawa-Ku, Osaka
Country
JAPANAddress
2-17-85, Jusohonmachi, , Yodogawa-Ku, Osaka, 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
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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2021 | 62IDA99ANTI-NEOPLASTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/12/2019 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/5/2017 | 62TCS99ANTI-SECRETORY N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 1/5/2017 | 62TCS99ANTI-SECRETORY N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 12/28/2016 | 62TCE02LANSOPRAZOLE (ANTI-SECRETORY) | Chicago District Office (CHI-DO) | |
| 4/18/2016 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | Chicago District Office (CHI-DO) | |
| 4/18/2016 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | Chicago District Office (CHI-DO) | |
| 7/26/2010 | 61CIA99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 7/26/2010 | 61CIA99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Chicago District Office (CHI-DO) |
| 11/3/2005 | 63XIS99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/3/2005 | 63XIS99DIAGOSTIC AID (DRUGS) N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Takeda Pharmaceutical Company Limited's FDA import refusal history?
Takeda Pharmaceutical Company Limited (FEI: 3002808311) has 11 FDA import refusal record(s) in our database, spanning from 11/3/2005 to 10/19/2021.
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 3002808311.
What types of violations has Takeda Pharmaceutical Company Limited received?
Takeda Pharmaceutical Company Limited has been cited for 4 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.