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Glaxo Smith Kline Australis Pty Ltd

⚠️ Moderate Risk

FEI: 3003444043 • Boronia, Victoria • AUSTRALIA

FEI

FEI Number

3003444043

📍

Location

Boronia, Victoria

🇦🇺

Country

AUSTRALIA
🏢

Address

1061 Mountain Hwy, , Boronia, Victoria, Australia

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/27/2012
Latest Refusal
7/27/2012
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
7/27/2012
63BDL02ALBUTEROL SULFATE (BRONCHODILATOR)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Glaxo Smith Kline Australis Pty Ltd's FDA import refusal history?

Glaxo Smith Kline Australis Pty Ltd (FEI: 3003444043) has 1 FDA import refusal record(s) in our database, spanning from 7/27/2012 to 7/27/2012.

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. Glaxo Smith Kline Australis Pty Ltd's FEI number is 3003444043.

What types of violations has Glaxo Smith Kline Australis Pty Ltd received?

Glaxo Smith Kline Australis Pty Ltd 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 Glaxo Smith Kline Australis Pty Ltd come from?

All FDA import refusal data for Glaxo Smith Kline Australis 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.