Glaxosmithkline Brasil Ltda
⚠️ Moderate Risk
FEI: 3004152717 • Rio De Janairo • BRAZIL
FEI Number
3004152717
Location
Rio De Janairo
Country
BRAZILAddress
Estrada Dos Bandelrantes, , Rio De Janairo, , Brazil
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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
Frequently Asked Questions
What is Glaxosmithkline Brasil Ltda's FDA import refusal history?
Glaxosmithkline Brasil Ltda (FEI: 3004152717) has 3 FDA import refusal record(s) in our database, spanning from 10/27/2011 to 7/29/2013.
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 Brasil Ltda's FEI number is 3004152717.
What types of violations has Glaxosmithkline Brasil Ltda received?
Glaxosmithkline Brasil 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 Brasil Ltda come from?
All FDA import refusal data for Glaxosmithkline Brasil 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.