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LABORATORIO FARSIMAN

⚠️ Moderate Risk

FEI: 3014670295 • Cortes • HONDURAS

FEI

FEI Number

3014670295

📍

Location

Cortes

🇭🇳

Country

HONDURAS
🏢

Address

1 Km Delante Del Peaje, , Cortes, , Honduras

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/19/2018
Latest Refusal
9/19/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

753×

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
9/19/2018
62GCH41IBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/19/2018
61TCH99ANTI-EMETIC/NAUSEANT N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/19/2018
56ICH76AZITHROMYCIN (MACAROLIDES)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIO FARSIMAN's FDA import refusal history?

LABORATORIO FARSIMAN (FEI: 3014670295) has 3 FDA import refusal record(s) in our database, spanning from 9/19/2018 to 9/19/2018.

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. LABORATORIO FARSIMAN's FEI number is 3014670295.

What types of violations has LABORATORIO FARSIMAN received?

LABORATORIO FARSIMAN 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 LABORATORIO FARSIMAN come from?

All FDA import refusal data for LABORATORIO FARSIMAN 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.