ImportRefusal LogoImportRefusal

Bresagen Limited

⚠️ Moderate Risk

FEI: 3002668937 • Adelaide • AUSTRALIA

FEI

FEI Number

3002668937

📍

Location

Adelaide

🇦🇺

Country

AUSTRALIA
🏢

Address

Po Box 259, , Adelaide, , Australia

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
10/23/2004
Latest Refusal
10/23/2004
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
10/23/2004
64ROL21SOMATROPIN (HORMONE)
72NEW VET DR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Bresagen Limited's FDA import refusal history?

Bresagen Limited (FEI: 3002668937) has 1 FDA import refusal record(s) in our database, spanning from 10/23/2004 to 10/23/2004.

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. Bresagen Limited's FEI number is 3002668937.

What types of violations has Bresagen Limited received?

Bresagen Limited 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 Bresagen Limited come from?

All FDA import refusal data for Bresagen Limited 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.