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QUIMICA ARISTON ECUADOR CIA LTDA

⚠️ Moderate Risk

FEI: 3012761739 • GUAYAQUIL • ECUADOR

FEI

FEI Number

3012761739

📍

Location

GUAYAQUIL

🇪🇨

Country

ECUADOR
🏢

Address

PISO-2-OFICINA 208, , GUAYAQUIL, , Ecuador

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/7/2016
Latest Refusal
10/7/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
10/7/2016
62LDY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is QUIMICA ARISTON ECUADOR CIA LTDA's FDA import refusal history?

QUIMICA ARISTON ECUADOR CIA LTDA (FEI: 3012761739) has 1 FDA import refusal record(s) in our database, spanning from 10/7/2016 to 10/7/2016.

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. QUIMICA ARISTON ECUADOR CIA LTDA's FEI number is 3012761739.

What types of violations has QUIMICA ARISTON ECUADOR CIA LTDA received?

QUIMICA ARISTON ECUADOR 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 QUIMICA ARISTON ECUADOR CIA LTDA come from?

All FDA import refusal data for QUIMICA ARISTON ECUADOR 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.