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LANDSTEINER SCIENTIFIC SA DE CV

⚠️ High Risk

FEI: 3020704424 • Toluca • MEXICO

FEI

FEI Number

3020704424

📍

Location

Toluca

🇲🇽

Country

MEXICO
🏢

Address

Prolongacion 4 Norte No234 Minzana F Lote 8, Col P, Toluca, , Mexico

High Risk

FDA Import Risk Assessment

56.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/17/2024
Latest Refusal
12/17/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
78.7×20%
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
12/17/2024
61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LANDSTEINER SCIENTIFIC SA DE CV's FDA import refusal history?

LANDSTEINER SCIENTIFIC SA DE CV (FEI: 3020704424) has 1 FDA import refusal record(s) in our database, spanning from 12/17/2024 to 12/17/2024.

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. LANDSTEINER SCIENTIFIC SA DE CV's FEI number is 3020704424.

What types of violations has LANDSTEINER SCIENTIFIC SA DE CV received?

LANDSTEINER SCIENTIFIC 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 LANDSTEINER SCIENTIFIC SA DE CV come from?

All FDA import refusal data for LANDSTEINER SCIENTIFIC 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.