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PRODEX CIA LTDA.

⚠️ High Risk

FEI: 3007322462 • Pedernales, Manabi • ECUADOR

FEI

FEI Number

3007322462

📍

Location

Pedernales, Manabi

🇪🇨

Country

ECUADOR
🏢

Address

Km 12,5 Via Pedernales Esmeraldas, , Pedernales, Manabi, Ecuador

High Risk

FDA Import Risk Assessment

57.0
LowModerateHighCritical

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

Statistics

7
Total Refusals
1
Unique Violations
3/3/2011
Latest Refusal
3/3/2011
Earliest Refusal

Score Breakdown

Violation Severity
100.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

97×

SALMONELLA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain Salmonella, a poisonous and deleterious substance which may render it injurious to health.

Refusal History

DateProductViolationsDivision
3/3/2011
16JGD05SHRIMP & PRAWNS
9SALMONELLA
New York District Office (NYK-DO)
3/3/2011
16JGD05SHRIMP & PRAWNS
9SALMONELLA
New York District Office (NYK-DO)
3/3/2011
16JGD05SHRIMP & PRAWNS
9SALMONELLA
New York District Office (NYK-DO)
3/3/2011
16JGD05SHRIMP & PRAWNS
9SALMONELLA
New York District Office (NYK-DO)
3/3/2011
16JGD05SHRIMP & PRAWNS
9SALMONELLA
New York District Office (NYK-DO)
3/3/2011
16JGD05SHRIMP & PRAWNS
9SALMONELLA
New York District Office (NYK-DO)
3/3/2011
16JGD05SHRIMP & PRAWNS
9SALMONELLA
New York District Office (NYK-DO)

Frequently Asked Questions

What is PRODEX CIA LTDA.'s FDA import refusal history?

PRODEX CIA LTDA. (FEI: 3007322462) has 7 FDA import refusal record(s) in our database, spanning from 3/3/2011 to 3/3/2011.

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. PRODEX CIA LTDA.'s FEI number is 3007322462.

What types of violations has PRODEX CIA LTDA. received?

PRODEX CIA LTDA. 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 PRODEX CIA LTDA. come from?

All FDA import refusal data for PRODEX 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.