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El Rosado S.A.

⚠️ Moderate Risk

FEI: 3007520360 • Guayaquil, Guayas • ECUADOR

FEI

FEI Number

3007520360

📍

Location

Guayaquil, Guayas

🇪🇨

Country

ECUADOR
🏢

Address

De Octubre 729 Y Boyaca 9, , Guayaquil, Guayas, Ecuador

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
6/12/2009
Latest Refusal
6/12/2009
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

622×

NEEDS FCE

It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).

Refusal History

DateProductViolationsDivision
6/12/2009
16AET33SARDINES (BRISLING, SPRATS, PILCHARDS, ETC.)
62NEEDS FCE
Los Angeles District Office (LOS-DO)
6/12/2009
16AEN45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
62NEEDS FCE
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is El Rosado S.A.'s FDA import refusal history?

El Rosado S.A. (FEI: 3007520360) has 2 FDA import refusal record(s) in our database, spanning from 6/12/2009 to 6/12/2009.

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. El Rosado S.A.'s FEI number is 3007520360.

What types of violations has El Rosado S.A. received?

El Rosado S.A. 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 El Rosado S.A. come from?

All FDA import refusal data for El Rosado 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.