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GLAXO SMITH KLINE B.V.

⚠️ Moderate Risk

FEI: 3004036041 • Zeist, Utrecht • NETHERLANDS

FEI

FEI Number

3004036041

📍

Location

Zeist, Utrecht

🇳🇱
🏢

Address

Huis Ter Heideweg 62, , Zeist, Utrecht, Netherlands

Moderate Risk

FDA Import Risk Assessment

41.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
9/15/2016
Latest Refusal
8/19/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
2.8×10%
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

752×

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
9/15/2016
63BAY25FLUTICASONE PROPIONATE (BRONCHODILATOR)
75UNAPPROVED
New York District Office (NYK-DO)
8/19/2009
61PIY61ROSIGLITAZONE MALEATE/METFORMIN HCI
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is GLAXO SMITH KLINE B.V.'s FDA import refusal history?

GLAXO SMITH KLINE B.V. (FEI: 3004036041) has 2 FDA import refusal record(s) in our database, spanning from 8/19/2009 to 9/15/2016.

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 B.V.'s FEI number is 3004036041.

What types of violations has GLAXO SMITH KLINE B.V. received?

GLAXO SMITH KLINE B.V. 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 B.V. come from?

All FDA import refusal data for GLAXO SMITH KLINE B.V. 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.