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Prebel Sede Productora

⚠️ Moderate Risk

FEI: 3009487024 • Medellin, Antioquia • COLOMBIA

FEI

FEI Number

3009487024

📍

Location

Medellin, Antioquia

🇨🇴

Country

COLOMBIA
🏢

Address

Carrera 59 10 131, , Medellin, Antioquia, Colombia

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/16/2009
Latest Refusal
10/16/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

3441×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

Refusal History

DateProductViolationsDivision
10/16/2009
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
344WARNINGS
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Prebel Sede Productora's FDA import refusal history?

Prebel Sede Productora (FEI: 3009487024) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2009 to 10/16/2009.

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. Prebel Sede Productora's FEI number is 3009487024.

What types of violations has Prebel Sede Productora received?

Prebel Sede Productora 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 Prebel Sede Productora come from?

All FDA import refusal data for Prebel Sede Productora 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.