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Glaxosmithkline Pty Ltd

⚠️ Moderate Risk

FEI: 3004172487 • Boronia • AUSTRALIA

FEI

FEI Number

3004172487

📍

Location

Boronia

🇦🇺

Country

AUSTRALIA
🏢

Address

1061 Mountian, , Boronia, , Australia

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/19/2003
Latest Refusal
11/19/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

3421×

PERSONALRX

The article appears to be a drug which requires a prescription from your doctor.

Refusal History

DateProductViolationsDivision
11/19/2003
61TNY99ANTI-EMETIC/NAUSEANT N.E.C.
342PERSONALRX
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Glaxosmithkline Pty Ltd's FDA import refusal history?

Glaxosmithkline Pty Ltd (FEI: 3004172487) has 1 FDA import refusal record(s) in our database, spanning from 11/19/2003 to 11/19/2003.

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. Glaxosmithkline Pty Ltd's FEI number is 3004172487.

What types of violations has Glaxosmithkline Pty Ltd received?

Glaxosmithkline 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 Glaxosmithkline Pty Ltd come from?

All FDA import refusal data for Glaxosmithkline 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.