ImportRefusal LogoImportRefusal

INTERNATIONAL BUSINESS DIV

✅ Low Risk

FEI: 3015911362 • Itagui • COLOMBIA

FEI

FEI Number

3015911362

📍

Location

Itagui

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 66a N43-02 Local, , Itagui, , Colombia

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
12/13/2019
Latest Refusal
12/13/2019
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
12/13/2019
79NAYSYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is INTERNATIONAL BUSINESS DIV's FDA import refusal history?

INTERNATIONAL BUSINESS DIV (FEI: 3015911362) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2019 to 12/13/2019.

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. INTERNATIONAL BUSINESS DIV's FEI number is 3015911362.

What types of violations has INTERNATIONAL BUSINESS DIV received?

INTERNATIONAL BUSINESS DIV 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 INTERNATIONAL BUSINESS DIV come from?

All FDA import refusal data for INTERNATIONAL BUSINESS DIV 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.