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GlaxoSmithKline South Africa (Pty) Ltd

⚠️ Moderate Risk

FEI: 3012621439 • Cape Town, 9460 • SOUTH AFRICA

FEI

FEI Number

3012621439

📍

Location

Cape Town, 9460

🇿🇦
🏢

Address

39 Hawkins Avenue, Epping Industria 1, Cape Town, 9460, South Africa

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/21/2016
Latest Refusal
10/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
10/21/2016
60WCB01ALBENDAZOLE (ANTHELMINTIC)
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is GlaxoSmithKline South Africa (Pty) Ltd's FDA import refusal history?

GlaxoSmithKline South Africa (Pty) Ltd (FEI: 3012621439) has 1 FDA import refusal record(s) in our database, spanning from 10/21/2016 to 10/21/2016.

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. GlaxoSmithKline South Africa (Pty) Ltd's FEI number is 3012621439.

What types of violations has GlaxoSmithKline South Africa (Pty) Ltd received?

GlaxoSmithKline South Africa (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 South Africa (Pty) Ltd come from?

All FDA import refusal data for GlaxoSmithKline South Africa (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.