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Abler Inc

⚠️ Moderate Risk

FEI: 3009109484 • Port Vila • VANUATU

FEI

FEI Number

3009109484

📍

Location

Port Vila

🇻🇺

Country

VANUATU
🏢

Address

PO Box 3370, , Port Vila, , Vanuatu

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/10/2011
Latest Refusal
11/10/2011
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

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.

Refusal History

DateProductViolationsDivision
11/10/2011
62KQY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
72NEW VET DR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Abler Inc's FDA import refusal history?

Abler Inc (FEI: 3009109484) has 1 FDA import refusal record(s) in our database, spanning from 11/10/2011 to 11/10/2011.

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. Abler Inc's FEI number is 3009109484.

What types of violations has Abler Inc received?

Abler Inc 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 Abler Inc come from?

All FDA import refusal data for Abler Inc 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.