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Glaxosmithkline Chile Farmaceutica Ltda

⚠️ High Risk

FEI: 3005129054 • Santiago • CHILE

FEI

FEI Number

3005129054

📍

Location

Santiago

🇨🇱

Country

CHILE
🏢

Address

P 19las Condes, Andes 2687bello, Santiago, , Chile

High Risk

FDA Import Risk Assessment

59.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

6
Total Refusals
1
Unique Violations
2/28/2025
Latest Refusal
9/24/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
31.3×30%
Recency
68.3×20%
Frequency
3.6×10%
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

756×

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
2/28/2025
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/20/2020
62VDC15TENOFOVIR DISOPROXIL FUMERATE
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/16/2020
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/20/2012
61MCB42LEVETIRACETAM (ANTI-CONVULSANT)
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/24/2008
62VCB52LEXIVA
75UNAPPROVED
New Orleans District Office (NOL-DO)
9/24/2008
66YCB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Glaxosmithkline Chile Farmaceutica Ltda's FDA import refusal history?

Glaxosmithkline Chile Farmaceutica Ltda (FEI: 3005129054) has 6 FDA import refusal record(s) in our database, spanning from 9/24/2008 to 2/28/2025.

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 Chile Farmaceutica Ltda's FEI number is 3005129054.

What types of violations has Glaxosmithkline Chile Farmaceutica Ltda received?

Glaxosmithkline Chile Farmaceutica Ltda 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 Chile Farmaceutica Ltda come from?

All FDA import refusal data for Glaxosmithkline Chile Farmaceutica Ltda 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.