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Laboratory Germn Ortiz

⚠️ Moderate Risk

FEI: 3005684294 • Bogota • COLOMBIA

FEI

FEI Number

3005684294

📍

Location

Bogota

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 24 N 1 81, , Bogota, , Colombia

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/7/2006
Latest Refusal
5/7/2006
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

3311×

DR QUALITC

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
5/7/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
331DR QUALITC
483DRUG NAME
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Laboratory Germn Ortiz's FDA import refusal history?

Laboratory Germn Ortiz (FEI: 3005684294) has 1 FDA import refusal record(s) in our database, spanning from 5/7/2006 to 5/7/2006.

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. Laboratory Germn Ortiz's FEI number is 3005684294.

What types of violations has Laboratory Germn Ortiz received?

Laboratory Germn Ortiz has been cited for 2 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 Laboratory Germn Ortiz come from?

All FDA import refusal data for Laboratory Germn Ortiz 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.