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UNIWU INTERNATIONAL SAS

⚠️ Moderate Risk

FEI: 3033024249 • Antiquia • COLOMBIA

FEI

FEI Number

3033024249

📍

Location

Antiquia

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 25 No 130 Medelli, , Antiquia, , Colombia

Moderate Risk

FDA Import Risk Assessment

40.2
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
12/30/2024
Latest Refusal
12/30/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
79.1×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
12/30/2024
85MOLCONDOM, NON-LATEX
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is UNIWU INTERNATIONAL SAS's FDA import refusal history?

UNIWU INTERNATIONAL SAS (FEI: 3033024249) has 1 FDA import refusal record(s) in our database, spanning from 12/30/2024 to 12/30/2024.

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. UNIWU INTERNATIONAL SAS's FEI number is 3033024249.

What types of violations has UNIWU INTERNATIONAL SAS received?

UNIWU INTERNATIONAL SAS 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 UNIWU INTERNATIONAL SAS come from?

All FDA import refusal data for UNIWU INTERNATIONAL SAS 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.