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Laboratorios Elea Mexico Sa De Cv

⚠️ Moderate Risk

FEI: 3012279989 • Mexicomexico • MEXICO

FEI

FEI Number

3012279989

📍

Location

Mexicomexico

🇲🇽

Country

MEXICO
🏢

Address

Marcelo 9del Vallebenito Juarez, , Mexicomexico, , 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
6/7/2016
Latest Refusal
6/7/2016
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
6/7/2016
64GCY07ESTRADIOL (ESTROGEN)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laboratorios Elea Mexico Sa De Cv's FDA import refusal history?

Laboratorios Elea Mexico Sa De Cv (FEI: 3012279989) has 1 FDA import refusal record(s) in our database, spanning from 6/7/2016 to 6/7/2016.

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. Laboratorios Elea Mexico Sa De Cv's FEI number is 3012279989.

What types of violations has Laboratorios Elea Mexico Sa De Cv received?

Laboratorios Elea 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 Laboratorios Elea Mexico Sa De Cv come from?

All FDA import refusal data for Laboratorios Elea 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.