Takeda Global Research & Development
⚠️ Moderate Risk
FEI: 3004447666 • Lake Forest, IL • UNITED STATES
FEI Number
3004447666
Location
Lake Forest, IL
Country
UNITED STATESAddress
675 N Field Dr, , Lake Forest, IL, United States
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2011 | 62TDC02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/18/2009 | 62TCA02LANSOPRAZOLE (ANTI-SECRETORY) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 8/15/2007 | 62ICK86LEUPROLIDE ACETATE (ANTI-NEOPLASTIC) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Takeda Global Research & Development's FDA import refusal history?
Takeda Global Research & Development (FEI: 3004447666) has 3 FDA import refusal record(s) in our database, spanning from 8/15/2007 to 10/27/2011.
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 Global Research & Development's FEI number is 3004447666.
What types of violations has Takeda Global Research & Development received?
Takeda Global Research & Development has been cited for 3 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 Global Research & Development come from?
All FDA import refusal data for Takeda Global Research & Development 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.