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Comercializadora Spb Sa

Low Risk

FEI: 3007501079 • Medellin • COLOMBIA

FEI

FEI Number

3007501079

📍

Location

Medellin

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 12 Sur N50g21, , Medellin, , Colombia

Low Risk

FDA Import Risk Assessment

23.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
8/18/2009
Latest Refusal
8/18/2009
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

732×

DRUG COLOR

The article appears to be a color additive the intended use of which is for the purpose of coloring only, and its packaging and labeling do not conform to regulations issued under section 721.

Refusal History

DateProductViolationsDivision
8/18/2009
50NGY29ZINC OXIDE
73DRUG COLOR
Florida District Office (FLA-DO)
8/18/2009
50NGY29ZINC OXIDE
73DRUG COLOR
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Comercializadora Spb Sa's FDA import refusal history?

Comercializadora Spb Sa (FEI: 3007501079) has 2 FDA import refusal record(s) in our database, spanning from 8/18/2009 to 8/18/2009.

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. Comercializadora Spb Sa's FEI number is 3007501079.

What types of violations has Comercializadora Spb Sa received?

Comercializadora Spb Sa 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 Comercializadora Spb Sa come from?

All FDA import refusal data for Comercializadora Spb Sa 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.