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Galeno

⚠️ High Risk

FEI: 3009508661 • Caracas • VENEZUELA

FEI

FEI Number

3009508661

📍

Location

Caracas

🇻🇪

Country

VENEZUELA
🏢

Address

Cl.Santa Ana,Edificio Saman Piso Pb, , Caracas, , Venezuela

High Risk

FDA Import Risk Assessment

59.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/27/2025
Latest Refusal
10/27/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
95.7×20%
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
10/27/2025
61FDY63RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Galeno's FDA import refusal history?

Galeno (FEI: 3009508661) has 1 FDA import refusal record(s) in our database, spanning from 10/27/2025 to 10/27/2025.

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. Galeno's FEI number is 3009508661.

What types of violations has Galeno received?

Galeno 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 Galeno come from?

All FDA import refusal data for Galeno 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.