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ANDRES BELLO

⚠️ Moderate Risk

FEI: 3022510828 • Rancheria La Ciudadela, Coahuila de Zaragoza • MEXICO

FEI

FEI Number

3022510828

📍

Location

Rancheria La Ciudadela, Coahuila de Zaragoza

🇲🇽

Country

MEXICO
🏢

Address

Polanco 45, San Pedro, Rancheria La Ciudadela, Coahuila de Zaragoza, Mexico

Moderate Risk

FDA Import Risk Assessment

43.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/13/2022
Latest Refusal
6/13/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
14.3×20%
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
6/13/2022
56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ANDRES BELLO's FDA import refusal history?

ANDRES BELLO (FEI: 3022510828) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2022 to 6/13/2022.

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. ANDRES BELLO's FEI number is 3022510828.

What types of violations has ANDRES BELLO received?

ANDRES BELLO 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 ANDRES BELLO come from?

All FDA import refusal data for ANDRES BELLO 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.