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ALRLEX DE MEXICO SA DE CV

⚠️ Moderate Risk

FEI: 3013042857 • Alvaro Obregon, Chiapas • MEXICO

FEI

FEI Number

3013042857

📍

Location

Alvaro Obregon, Chiapas

🇲🇽

Country

MEXICO
🏢

Address

Puerto Acapulco No 35 C, Col. San Sebastian, Tapachula, Alvaro Obregon, Chiapas, 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
2/21/2018
Latest Refusal
2/21/2018
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
2/21/2018
62TCA02LANSOPRAZOLE (ANTI-SECRETORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

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

ALRLEX DE MEXICO SA DE CV (FEI: 3013042857) has 1 FDA import refusal record(s) in our database, spanning from 2/21/2018 to 2/21/2018.

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. ALRLEX DE MEXICO SA DE CV's FEI number is 3013042857.

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

ALRLEX DE 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 ALRLEX DE MEXICO SA DE CV come from?

All FDA import refusal data for ALRLEX DE 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.