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Rosa Giraldo Vanegas

⚠️ Moderate Risk

FEI: 3011802608 • Armeniaarmenia • COLOMBIA

FEI

FEI Number

3011802608

📍

Location

Armeniaarmenia

🇨🇴

Country

COLOMBIA
🏢

Address

Avenida Bolivar 5norte 89, , Armeniaarmenia, , 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
1/28/2016
Latest Refusal
1/28/2016
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
1/28/2016
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Rosa Giraldo Vanegas's FDA import refusal history?

Rosa Giraldo Vanegas (FEI: 3011802608) has 1 FDA import refusal record(s) in our database, spanning from 1/28/2016 to 1/28/2016.

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. Rosa Giraldo Vanegas's FEI number is 3011802608.

What types of violations has Rosa Giraldo Vanegas received?

Rosa Giraldo Vanegas 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 Rosa Giraldo Vanegas come from?

All FDA import refusal data for Rosa Giraldo Vanegas 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.