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Novartis Animal Health Australia

⚠️ Moderate Risk

FEI: 3002679978 • Wentworthville, NSW • AUSTRALIA

FEI

FEI Number

3002679978

📍

Location

Wentworthville, NSW

🇦🇺

Country

AUSTRALIA
🏢

Address

140-150 Bungaree Road, , Wentworthville, NSW, Australia

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/15/2003
Latest Refusal
8/15/2003
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

3431×

VET LEGEND

The article appears to be a veterinary drug without the "Caution" statement as required by Section 503(f)(4).

Refusal History

DateProductViolationsDivision
8/15/2003
68HAJ10SMALL ANIMAL PARASITICIDES (EXTERNAL)
343VET LEGEND
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Novartis Animal Health Australia's FDA import refusal history?

Novartis Animal Health Australia (FEI: 3002679978) has 1 FDA import refusal record(s) in our database, spanning from 8/15/2003 to 8/15/2003.

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. Novartis Animal Health Australia's FEI number is 3002679978.

What types of violations has Novartis Animal Health Australia received?

Novartis Animal Health Australia 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 Novartis Animal Health Australia come from?

All FDA import refusal data for Novartis Animal Health Australia 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.