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Empacadora Coral del Pacifico EMCOPAC S.A.

⚠️ High Risk

FEI: 3009909947 • Esmeraldas, Esmeraldas • ECUADOR

FEI

FEI Number

3009909947

📍

Location

Esmeraldas, Esmeraldas

🇪🇨

Country

ECUADOR
🏢

Address

Calle Principal S/N, Parroquia Luis Tello, Esmeraldas, Esmeraldas, Ecuador

High Risk

FDA Import Risk Assessment

66.2
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

14
Total Refusals
4
Unique Violations
12/13/2024
Latest Refusal
6/24/2008
Earliest Refusal

Score Breakdown

Violation Severity
98.4×40%
Refusal Volume
43.6×30%
Recency
64.4×20%
Frequency
8.5×10%
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

24911×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

23603×

HISTAMINE

The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.

2513×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

38782×

POISONORD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance which would ordinarily render the article injurious to health. Contains:

Refusal History

DateProductViolationsDivision
12/13/2024
16AGC51MAHI MAHI
2360HISTAMINE
249FILTHY
Division of West Coast Imports (DWCI)
10/18/2024
16AGC51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
10/17/2024
16AGC51MAHI MAHI
2360HISTAMINE
249FILTHY
Division of Southeast Imports (DSEI)
5/7/2024
16AGC51MAHI MAHI
249FILTHY
3878POISONORD
Division of West Coast Imports (DWCI)
5/3/2024
16AGC51MAHI MAHI
2360HISTAMINE
249FILTHY
Division of Southeast Imports (DSEI)
5/3/2024
16AGC51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
4/29/2024
16AGC51MAHI MAHI
249FILTHY
3878POISONORD
Division of Southeast Imports (DSEI)
4/26/2024
16AGC51MAHI MAHI
249FILTHY
Division of West Coast Imports (DWCI)
4/26/2024
16AGC51MAHI MAHI
249FILTHY
Division of West Coast Imports (DWCI)
4/8/2024
16AVT51MAHI MAHI
249FILTHY
Division of Northeast Imports (DNEI)
10/1/2018
16AGD51MAHI MAHI
249FILTHY
Division of Southeast Imports (DSEI)
6/24/2009
16AGC42SWORDFISH
251POISONOUS
Florida District Office (FLA-DO)
6/24/2008
16AGC42SWORDFISH
251POISONOUS
Florida District Office (FLA-DO)
6/24/2008
16AGC42SWORDFISH
251POISONOUS
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Empacadora Coral del Pacifico EMCOPAC S.A.'s FDA import refusal history?

Empacadora Coral del Pacifico EMCOPAC S.A. (FEI: 3009909947) has 14 FDA import refusal record(s) in our database, spanning from 6/24/2008 to 12/13/2024.

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. Empacadora Coral del Pacifico EMCOPAC S.A.'s FEI number is 3009909947.

What types of violations has Empacadora Coral del Pacifico EMCOPAC S.A. received?

Empacadora Coral del Pacifico EMCOPAC S.A. has been cited for 4 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 Empacadora Coral del Pacifico EMCOPAC S.A. come from?

All FDA import refusal data for Empacadora Coral del Pacifico EMCOPAC S.A. 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.