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AVIHOL CIA

⚠️ High Risk

FEI: 3032747287 • Quito • ECUADOR

FEI

FEI Number

3032747287

📍

Location

Quito

🇪🇨

Country

ECUADOR
🏢

Address

Bernardino Echeverria A, , Quito, , Ecuador

High Risk

FDA Import Risk Assessment

54.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/12/2024
Latest Refusal
12/12/2024
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
11.2×30%
Recency
78.1×20%
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

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

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
12/12/2024
66VOY99MISCELLANEOUS PATENT MEDICINES, ETC.
72NEW VET DR
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is AVIHOL CIA's FDA import refusal history?

AVIHOL CIA (FEI: 3032747287) has 1 FDA import refusal record(s) in our database, spanning from 12/12/2024 to 12/12/2024.

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. AVIHOL CIA's FEI number is 3032747287.

What types of violations has AVIHOL CIA received?

AVIHOL CIA has been cited for 2 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 AVIHOL CIA come from?

All FDA import refusal data for AVIHOL CIA 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.