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GENFAR

⚠️ High Risk

FEI: 3028015453 • Medellin • COLOMBIA

FEI

FEI Number

3028015453

📍

Location

Medellin

🇨🇴

Country

COLOMBIA
🏢

Address

Colsubsidio Sura Belen, , Medellin, , Colombia

High Risk

FDA Import Risk Assessment

57.7
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
10/12/2023
Latest Refusal
10/12/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
40.5×20%
Frequency
50.0×10%
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

755×

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
10/12/2023
66JCE01LEVOTHYROXINE SODIUM (THYROID HORMONE)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/12/2023
61TCE06DIMENHYDRINATE (ANTI-EMETIC/NAUSEANT)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/12/2023
62OCE41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/12/2023
62OCE28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/12/2023
64BCE24FUROSEMIDE (DIURETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GENFAR's FDA import refusal history?

GENFAR (FEI: 3028015453) has 5 FDA import refusal record(s) in our database, spanning from 10/12/2023 to 10/12/2023.

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. GENFAR's FEI number is 3028015453.

What types of violations has GENFAR received?

GENFAR 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 GENFAR come from?

All FDA import refusal data for GENFAR 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.