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Glaxosmithkline Israel Ltd

⚠️ Moderate Risk

FEI: 3004637736 • Petah Tikva • ISRAEL

FEI

FEI Number

3004637736

📍

Location

Petah Tikva

🇮🇱

Country

ISRAEL
🏢

Address

25 Bazel St. 2nd Floor, , Petah Tikva, , Israel

Moderate Risk

FDA Import Risk Assessment

43.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
10/28/2011
Latest Refusal
4/9/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
8.4×10%
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
10/28/2011
61NCB77PAROXETINE HCL (ANTI-DEPRESSANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)
10/27/2011
61HCA43LEVOFLOXACIN (ANTI-BACTERIAL, PART III)
75UNAPPROVED
New Orleans District Office (NOL-DO)
4/9/2008
64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

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

Glaxosmithkline Israel Ltd (FEI: 3004637736) has 3 FDA import refusal record(s) in our database, spanning from 4/9/2008 to 10/28/2011.

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 Israel Ltd's FEI number is 3004637736.

What types of violations has Glaxosmithkline Israel Ltd received?

Glaxosmithkline Israel 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 Israel Ltd come from?

All FDA import refusal data for Glaxosmithkline Israel 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.