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Pasar Express Sa Efectivo Ops

⚠️ Moderate Risk

FEI: 3004901953 • Bogata • COLOMBIA

FEI

FEI Number

3004901953

📍

Location

Bogata

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 100 Nro 19 61 Of 608, , Bogata, , 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
2/18/2005
Latest Refusal
2/18/2005
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
2/18/2005
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pasar Express Sa Efectivo Ops's FDA import refusal history?

Pasar Express Sa Efectivo Ops (FEI: 3004901953) has 1 FDA import refusal record(s) in our database, spanning from 2/18/2005 to 2/18/2005.

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. Pasar Express Sa Efectivo Ops's FEI number is 3004901953.

What types of violations has Pasar Express Sa Efectivo Ops received?

Pasar Express Sa Efectivo Ops 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 Pasar Express Sa Efectivo Ops come from?

All FDA import refusal data for Pasar Express Sa Efectivo Ops 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.