Takeda Mexico S.A. De C.V.
⚠️ High Risk
FEI: 3010380804 • Estado De Mexico • MEXICO
FEI Number
3010380804
Location
Estado De Mexico
Country
MEXICOAddress
Av. Primero De Mayo No. 130 Industrial, , Estado De 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/6/2022 | 60SBR10MAGALDRATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2021 | 60SCL10MAGALDRATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/22/2020 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2020 | 62TCA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/31/2019 | 61PDB26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/31/2019 | 61CCL99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/16/2019 | 62GDO99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Takeda Mexico S.A. De C.V.'s FDA import refusal history?
Takeda Mexico S.A. De C.V. (FEI: 3010380804) has 7 FDA import refusal record(s) in our database, spanning from 7/16/2019 to 9/6/2022.
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 S.A. De C.V.'s FEI number is 3010380804.
What types of violations has Takeda Mexico S.A. De C.V. received?
Takeda Mexico S.A. De C.V. has been cited for 1 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 S.A. De C.V. come from?
All FDA import refusal data for Takeda Mexico S.A. De C.V. 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.