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Access Animal Health Agencies Pty Ltd

⚠️ Moderate Risk

FEI: 3003808210 • Roseville, New South Wales • AUSTRALIA

FEI

FEI Number

3003808210

📍

Location

Roseville, New South Wales

🇦🇺

Country

AUSTRALIA
🏢

Address

Po Box 590, , Roseville, New South Wales, Australia

Moderate Risk

FDA Import Risk Assessment

30.7
LowModerateHighCritical

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

Statistics

6
Total Refusals
3
Unique Violations
1/21/2003
Latest Refusal
1/21/2003
Earliest Refusal

Score Breakdown

Violation Severity
38.3×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

4723×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

28802×

RXCOMPOUND

the labeling fails to bear, at a minimum, the symbol "Rx only."

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
1/21/2003
68YCA20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES
2880RXCOMPOUND
New Orleans District Office (NOL-DO)
1/21/2003
68YCA20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES
2880RXCOMPOUND
New Orleans District Office (NOL-DO)
1/21/2003
68YCA20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES
472NO ENGLISH
New Orleans District Office (NOL-DO)
1/21/2003
68HBK10SMALL ANIMAL PARASITICIDES (EXTERNAL)
472NO ENGLISH
New Orleans District Office (NOL-DO)
1/21/2003
68HBK10SMALL ANIMAL PARASITICIDES (EXTERNAL)
472NO ENGLISH
New Orleans District Office (NOL-DO)
1/21/2003
68YCA20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES
343VET LEGEND
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Access Animal Health Agencies Pty Ltd's FDA import refusal history?

Access Animal Health Agencies Pty Ltd (FEI: 3003808210) has 6 FDA import refusal record(s) in our database, spanning from 1/21/2003 to 1/21/2003.

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. Access Animal Health Agencies Pty Ltd's FEI number is 3003808210.

What types of violations has Access Animal Health Agencies Pty Ltd received?

Access Animal Health Agencies Pty Ltd has been cited for 3 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 Access Animal Health Agencies Pty Ltd come from?

All FDA import refusal data for Access Animal Health Agencies Pty Ltd 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.