TAKEDA MEXICO SA DE CEV
⚠️ High Risk
FEI: 3012434729 • Naucalpan de Juarez, Mexico • MEXICO
FEI Number
3012434729
Location
Naucalpan de Juarez, Mexico
Country
MEXICOAddress
Avenida Primero de Mayo 130, Parque Industrial Naucalpan, Naucalpan de Juarez, Mexico, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/27/2025 | 54BFA07IRON (MINERAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/12/2019 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/11/2018 | 60SDY10MAGALDRATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2017 | 62CCB02ALTHIAZIDE (ANTI-HYPERTENSIVE) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 11/28/2017 | 62VCB30INDINAVIR SULFATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/2/2017 | 61VDA01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/31/2017 | 65BCA03CARBOCYSTEINE (MUCOLYTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/11/2017 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is TAKEDA MEXICO SA DE CEV's FDA import refusal history?
TAKEDA MEXICO SA DE CEV (FEI: 3012434729) has 9 FDA import refusal record(s) in our database, spanning from 1/11/2017 to 5/27/2025.
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 MEXICO SA DE CEV's FEI number is 3012434729.
What types of violations has TAKEDA MEXICO SA DE CEV received?
TAKEDA MEXICO SA DE CEV 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 MEXICO SA DE CEV come from?
All FDA import refusal data for TAKEDA MEXICO SA DE CEV 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.