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Promarosa (Productos del Mar Santa Rosa Cia. Ltda.)

⚠️ Moderate Risk

FEI: 3000181496 • Guayaquil, Guayas • ECUADOR

FEI

FEI Number

3000181496

📍

Location

Guayaquil, Guayas

🇪🇨

Country

ECUADOR
🏢

Address

10 de Augosto 103 y Malecon P.B. Ofc. 11, , Guayaquil, Guayas, Ecuador

Moderate Risk

FDA Import Risk Assessment

46.4
LowModerateHighCritical

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

Statistics

4
Total Refusals
3
Unique Violations
6/2/2006
Latest Refusal
7/18/2002
Earliest Refusal

Score Breakdown

Violation Severity
94.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
10.3×10%
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

23602×

HISTAMINE

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

2492×

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.

3081×

MFR INSAN

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

Refusal History

DateProductViolationsDivision
6/2/2006
16AGC17GROUPERS
308MFR INSAN
Florida District Office (FLA-DO)
10/5/2002
16AGC69ESCOLAR
2360HISTAMINE
249FILTHY
Florida District Office (FLA-DO)
8/13/2002
16AGC69ESCOLAR
249FILTHY
Florida District Office (FLA-DO)
7/18/2002
16AGC69ESCOLAR
2360HISTAMINE
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Promarosa (Productos del Mar Santa Rosa Cia. Ltda.)'s FDA import refusal history?

Promarosa (Productos del Mar Santa Rosa Cia. Ltda.) (FEI: 3000181496) has 4 FDA import refusal record(s) in our database, spanning from 7/18/2002 to 6/2/2006.

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. Promarosa (Productos del Mar Santa Rosa Cia. Ltda.)'s FEI number is 3000181496.

What types of violations has Promarosa (Productos del Mar Santa Rosa Cia. Ltda.) received?

Promarosa (Productos del Mar Santa Rosa Cia. Ltda.) has been cited for 3 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 Promarosa (Productos del Mar Santa Rosa Cia. Ltda.) come from?

All FDA import refusal data for Promarosa (Productos del Mar Santa Rosa Cia. Ltda.) 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.