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SA DE CV TAKEDA MEXICO

⚠️ Moderate Risk

FEI: 3012949778 • Naucalpan de Juarez, Mexico • MEXICO

FEI

FEI Number

3012949778

📍

Location

Naucalpan de Juarez, Mexico

🇲🇽

Country

MEXICO
🏢

Address

May First Avenue Number, Zona Industrial Naucalpan, Naucalpan de Juarez, Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
12/21/2016
Latest Refusal
12/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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
12/21/2016
64NDC07IRON DEXTRAN (INJ) (HEMATINIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

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

SA DE CV TAKEDA MEXICO (FEI: 3012949778) has 1 FDA import refusal record(s) in our database, spanning from 12/21/2016 to 12/21/2016.

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. SA DE CV TAKEDA MEXICO's FEI number is 3012949778.

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

SA DE CV TAKEDA MEXICO 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 SA DE CV TAKEDA MEXICO come from?

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