ImportRefusal LogoImportRefusal

FRANCO COLOMBIANO LAFRANCOL S A

⚠️ High Risk

FEI: 3013577142 • Cali, Valle Del Cauca • COLOMBIA

FEI

FEI Number

3013577142

📍

Location

Cali, Valle Del Cauca

🇨🇴

Country

COLOMBIA
🏢

Address

Carrera 1 46a 125, , Cali, Valle Del Cauca, Colombia

High Risk

FDA Import Risk Assessment

61.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/30/2025
Latest Refusal
10/12/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
99.4×20%
Frequency
2.4×10%
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

752×

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
12/30/2025
66SCA51TADALAFIL
75UNAPPROVED
Division of Southeast Imports (DSEI)
10/12/2017
56EDB22DOXYCYCLINE HYCLATE (TETRACYCLINES)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FRANCO COLOMBIANO LAFRANCOL S A's FDA import refusal history?

FRANCO COLOMBIANO LAFRANCOL S A (FEI: 3013577142) has 2 FDA import refusal record(s) in our database, spanning from 10/12/2017 to 12/30/2025.

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. FRANCO COLOMBIANO LAFRANCOL S A's FEI number is 3013577142.

What types of violations has FRANCO COLOMBIANO LAFRANCOL S A received?

FRANCO COLOMBIANO LAFRANCOL S A 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 FRANCO COLOMBIANO LAFRANCOL S A come from?

All FDA import refusal data for FRANCO COLOMBIANO LAFRANCOL S A 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.