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Empacadora Bilbo S.A. DBA Bilbosa

⚠️ High Risk

FEI: 3004290156 • Montecristi, Manabi • ECUADOR

FEI

FEI Number

3004290156

📍

Location

Montecristi, Manabi

🇪🇨

Country

ECUADOR
🏢

Address

Ciudadela Monterrey, Carretera Manta - Montecristi Km 6. 5, Montecristi, Manabi, Ecuador

High Risk

FDA Import Risk Assessment

51.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/18/2024
Latest Refusal
10/18/2024
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
75.0×20%
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

25801×

MFRHACCP

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Act in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been rendered injurious to health in that it appears to have been processed in violation of 21 CFR 123.6(a) and 123.8(a).

Refusal History

DateProductViolationsDivision
10/18/2024
16AVT45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
2580MFRHACCP
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Empacadora Bilbo S.A. DBA Bilbosa's FDA import refusal history?

Empacadora Bilbo S.A. DBA Bilbosa (FEI: 3004290156) has 1 FDA import refusal record(s) in our database, spanning from 10/18/2024 to 10/18/2024.

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 Bilbo S.A. DBA Bilbosa's FEI number is 3004290156.

What types of violations has Empacadora Bilbo S.A. DBA Bilbosa received?

Empacadora Bilbo S.A. DBA Bilbosa 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 Empacadora Bilbo S.A. DBA Bilbosa come from?

All FDA import refusal data for Empacadora Bilbo S.A. DBA Bilbosa 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.