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Margarita Giraldo

⚠️ Moderate Risk

FEI: 3004983338 • Bogota • COLOMBIA

FEI

FEI Number

3004983338

📍

Location

Bogota

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 125 Nro 37-20 Apt 207, , Bogota, , Colombia

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/29/2005
Latest Refusal
3/29/2005
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

30001×

N-RX INACT

The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.

Refusal History

DateProductViolationsDivision
3/29/2005
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
3000N-RX INACT
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Margarita Giraldo's FDA import refusal history?

Margarita Giraldo (FEI: 3004983338) has 1 FDA import refusal record(s) in our database, spanning from 3/29/2005 to 3/29/2005.

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. Margarita Giraldo's FEI number is 3004983338.

What types of violations has Margarita Giraldo received?

Margarita Giraldo 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 Margarita Giraldo come from?

All FDA import refusal data for Margarita Giraldo 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.