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Maria De Lourdes Garcia Elizal

⚠️ Moderate Risk

FEI: 3005223973 • Mexico • MEXICO

FEI

FEI Number

3005223973

📍

Location

Mexico

🇲🇽

Country

MEXICO
🏢

Address

De / Gael-470731-Q84, , Mexico, , Mexico

Moderate Risk

FDA Import Risk Assessment

46.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/20/2023
Latest Refusal
3/20/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
29.7×20%
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
3/20/2023
56YBA99ANTIBIOTIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Maria De Lourdes Garcia Elizal's FDA import refusal history?

Maria De Lourdes Garcia Elizal (FEI: 3005223973) has 1 FDA import refusal record(s) in our database, spanning from 3/20/2023 to 3/20/2023.

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. Maria De Lourdes Garcia Elizal's FEI number is 3005223973.

What types of violations has Maria De Lourdes Garcia Elizal received?

Maria De Lourdes Garcia Elizal 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 Maria De Lourdes Garcia Elizal come from?

All FDA import refusal data for Maria De Lourdes Garcia Elizal 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.