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Glaxo Operations UK Limited

⚠️ Moderate Risk

FEI: 3002807081 • Liverpool • UNITED KINGDOM

FEI

FEI Number

3002807081

📍

Location

Liverpool

🇬🇧
🏢

Address

Speke Boulevard, , Liverpool, , United Kingdom

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/8/2004
Latest Refusal
7/28/2004
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1153×

DR QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.

Refusal History

DateProductViolationsDivision
11/8/2004
63BCQ01ALBUTEROL (BRONCHODILATOR)
115DR QUALITY
Baltimore District Office (BLT-DO)
11/8/2004
63BCQ01ALBUTEROL (BRONCHODILATOR)
115DR QUALITY
Baltimore District Office (BLT-DO)
7/28/2004
63BCQ01ALBUTEROL (BRONCHODILATOR)
115DR QUALITY
Baltimore District Office (BLT-DO)

Frequently Asked Questions

What is Glaxo Operations UK Limited's FDA import refusal history?

Glaxo Operations UK Limited (FEI: 3002807081) has 3 FDA import refusal record(s) in our database, spanning from 7/28/2004 to 11/8/2004.

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. Glaxo Operations UK Limited's FEI number is 3002807081.

What types of violations has Glaxo Operations UK Limited received?

Glaxo Operations UK 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 Glaxo Operations UK Limited come from?

All FDA import refusal data for Glaxo Operations UK 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.