ImportRefusal LogoImportRefusal

TAKEDA MEXICO SA DE CV

⚠️ High Risk

FEI: 3027530025 • Mexico City • MEXICO

FEI

FEI Number

3027530025

📍

Location

Mexico City

🇲🇽

Country

MEXICO
🏢

Address

Av Carlos Fernandez, , Mexico City, , Mexico

High Risk

FDA Import Risk Assessment

58.2
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
6/30/2025
Latest Refusal
6/30/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
89.1×20%
Frequency
10.0×10%
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

751×

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

DateProductViolationsDivision
6/30/2025
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is TAKEDA MEXICO SA DE CV's FDA import refusal history?

TAKEDA MEXICO SA DE CV (FEI: 3027530025) has 1 FDA import refusal record(s) in our database, spanning from 6/30/2025 to 6/30/2025.

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 CV's FEI number is 3027530025.

What types of violations has TAKEDA MEXICO SA DE CV received?

TAKEDA MEXICO SA DE CV 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 SA DE CV come from?

All FDA import refusal data for TAKEDA MEXICO SA DE CV 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.