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ELABORADO POR LA FABRIFARMA SA

⚠️ High Risk

FEI: 3015454684 • Bogota, Cundinamarca • COLOMBIA

FEI

FEI Number

3015454684

📍

Location

Bogota, Cundinamarca

🇨🇴

Country

COLOMBIA
🏢

Address

Carrera 16 75 23, , Bogota, Cundinamarca, Colombia

High Risk

FDA Import Risk Assessment

59.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/5/2025
Latest Refusal
12/5/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
98.0×20%
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
12/5/2025
61MCA41VALPROIC ACID (ANTI-CONVULSANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ELABORADO POR LA FABRIFARMA SA's FDA import refusal history?

ELABORADO POR LA FABRIFARMA SA (FEI: 3015454684) has 1 FDA import refusal record(s) in our database, spanning from 12/5/2025 to 12/5/2025.

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. ELABORADO POR LA FABRIFARMA SA's FEI number is 3015454684.

What types of violations has ELABORADO POR LA FABRIFARMA SA received?

ELABORADO POR LA FABRIFARMA SA 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 ELABORADO POR LA FABRIFARMA SA come from?

All FDA import refusal data for ELABORADO POR LA FABRIFARMA SA 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.