ImportRefusal LogoImportRefusal

Glaxosmithkline Pharmaceuticals

⚠️ Moderate Risk

FEI: 3012212307 • Lagos, Cross River State • NIGERIA

FEI

FEI Number

3012212307

📍

Location

Lagos, Cross River State

🇳🇬

Country

NIGERIA
🏢

Address

Agbaso Rd Agbara, , Lagos, Cross River State, Nigeria

Moderate Risk

FDA Import Risk Assessment

47.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/29/2022
Latest Refusal
4/20/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
22.6×20%
Frequency
4.5×10%
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
11/29/2022
63BCV25FLUTICASONE PROPIONATE (BRONCHODILATOR)
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/20/2016
60LBO99ANALGESIC, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)
4/20/2016
60SAZ99ANTACID, N.E.C.
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Glaxosmithkline Pharmaceuticals's FDA import refusal history?

Glaxosmithkline Pharmaceuticals (FEI: 3012212307) has 3 FDA import refusal record(s) in our database, spanning from 4/20/2016 to 11/29/2022.

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 Pharmaceuticals's FEI number is 3012212307.

What types of violations has Glaxosmithkline Pharmaceuticals received?

Glaxosmithkline Pharmaceuticals 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 Pharmaceuticals come from?

All FDA import refusal data for Glaxosmithkline Pharmaceuticals 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.