GlaxoSmithKline
✅ Low Risk
FEI: 3010063478 • Madrid • SPAIN
FEI Number
3010063478
Location
Madrid
Country
SPAINAddress
28806 Alcala de Henares, , Madrid, , Spain
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/20/2013 | 61MBZ11MAGNESIUM SULFATE (ANTI-CONVULSANT) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is GlaxoSmithKline's FDA import refusal history?
GlaxoSmithKline (FEI: 3010063478) has 1 FDA import refusal record(s) in our database, spanning from 5/20/2013 to 5/20/2013.
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's FEI number is 3010063478.
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.