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COFIMAR SA II

⚠️ Moderate Risk

FEI: 3028879328 • Guayaquil, Guayas • ECUADOR

FEI

FEI Number

3028879328

📍

Location

Guayaquil, Guayas

🇪🇨

Country

ECUADOR
🏢

Address

Calle Mirtos Interseccion Casuarina, Solar 31 Manzana 3, Guayaquil, Guayas, Ecuador

Moderate Risk

FDA Import Risk Assessment

47.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/29/2023
Latest Refusal
11/29/2023
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
57.1×20%
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

28601×

VETDRUGRES

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a new animal drug (or conversion product thereof) that is unsafe within the meaning of Section 512. Product contains

Refusal History

DateProductViolationsDivision
11/29/2023
16JGT05SHRIMP & PRAWNS
2860VETDRUGRES
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is COFIMAR SA II's FDA import refusal history?

COFIMAR SA II (FEI: 3028879328) has 1 FDA import refusal record(s) in our database, spanning from 11/29/2023 to 11/29/2023.

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. COFIMAR SA II's FEI number is 3028879328.

What types of violations has COFIMAR SA II received?

COFIMAR SA II 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 COFIMAR SA II come from?

All FDA import refusal data for COFIMAR SA II 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.