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ELQUIN DE JESUS DURANGO ALVAREZ

⚠️ Moderate Risk

FEI: 3017122359 • Pereira • COLOMBIA

FEI

FEI Number

3017122359

📍

Location

Pereira

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 19 4 26 Belalcazar Calda, , Pereira, , Colombia

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
8/25/2020
Latest Refusal
8/25/2020
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
8/25/2020
64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ELQUIN DE JESUS DURANGO ALVAREZ's FDA import refusal history?

ELQUIN DE JESUS DURANGO ALVAREZ (FEI: 3017122359) has 1 FDA import refusal record(s) in our database, spanning from 8/25/2020 to 8/25/2020.

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. ELQUIN DE JESUS DURANGO ALVAREZ's FEI number is 3017122359.

What types of violations has ELQUIN DE JESUS DURANGO ALVAREZ received?

ELQUIN DE JESUS DURANGO ALVAREZ 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 ELQUIN DE JESUS DURANGO ALVAREZ come from?

All FDA import refusal data for ELQUIN DE JESUS DURANGO ALVAREZ 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.