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WEST QUIMICA POR LA VIDA

⚠️ High Risk

FEI: 3031028946 • Antioquia • COLOMBIA

FEI

FEI Number

3031028946

📍

Location

Antioquia

🇨🇴

Country

COLOMBIA
🏢

Address

Carrera 50 No 76 D Sur, , Antioquia, , Colombia

High Risk

FDA Import Risk Assessment

54.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
7/11/2024
Latest Refusal
7/11/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
69.6×20%
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
7/11/2024
61LCL14CHLORHEXIDINE GLUCONATE
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is WEST QUIMICA POR LA VIDA's FDA import refusal history?

WEST QUIMICA POR LA VIDA (FEI: 3031028946) has 1 FDA import refusal record(s) in our database, spanning from 7/11/2024 to 7/11/2024.

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. WEST QUIMICA POR LA VIDA's FEI number is 3031028946.

What types of violations has WEST QUIMICA POR LA VIDA received?

WEST QUIMICA POR LA VIDA 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 WEST QUIMICA POR LA VIDA come from?

All FDA import refusal data for WEST QUIMICA POR LA VIDA 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.