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Glaxo Saudi Arabia Ltd

⚠️ Moderate Risk

FEI: 3003945493 • Riyadh • SAUDI ARABIA

FEI

FEI Number

3003945493

📍

Location

Riyadh

🇸🇦
🏢

Address

Mousa Bin Nosair St,Behind Kfc Olaya3rd, , Riyadh, , Saudi Arabia

Moderate Risk

FDA Import Risk Assessment

43.1
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
5/25/2010
Latest Refusal
4/28/2003
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
4.2×10%
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

753×

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
5/25/2010
64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
Southwest Import District Office (SWI-DO)
6/5/2009
53GC09FACE MAKEUP KITS (MAKEUP PREPARATIONS, NOT FOR EYES)
75UNAPPROVED
Southwest Import District Office (SWI-DO)
4/28/2003
64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Glaxo Saudi Arabia Ltd's FDA import refusal history?

Glaxo Saudi Arabia Ltd (FEI: 3003945493) has 3 FDA import refusal record(s) in our database, spanning from 4/28/2003 to 5/25/2010.

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 Saudi Arabia Ltd's FEI number is 3003945493.

What types of violations has Glaxo Saudi Arabia Ltd received?

Glaxo Saudi Arabia 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 Saudi Arabia Ltd come from?

All FDA import refusal data for Glaxo Saudi Arabia 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.