ImportRefusal LogoImportRefusal

Glaxosmithkline

⚠️ Moderate Risk

FEI: 3004865210 • Cairo, Cairo • EGYPT

FEI

FEI Number

3004865210

📍

Location

Cairo, Cairo

🇪🇬

Country

EGYPT
🏢

Address

11491 El Salam City, , Cairo, Cairo, Egypt

Moderate Risk

FDA Import Risk Assessment

41.7
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
6/29/2012
Latest Refusal
7/5/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.0×10%
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

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
6/29/2012
62OCC24DILTIAZEM HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II)
75UNAPPROVED
New Orleans District Office (NOL-DO)
7/5/2007
60LCB01ACETAMINOPHEN (ANALGESIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Glaxosmithkline's FDA import refusal history?

Glaxosmithkline (FEI: 3004865210) has 2 FDA import refusal record(s) in our database, spanning from 7/5/2007 to 6/29/2012.

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's FEI number is 3004865210.

What types of violations has Glaxosmithkline received?

Glaxosmithkline 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 come from?

All FDA import refusal data for Glaxosmithkline 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.