GLAXOSMITHKLINE MEXICO SA DE CV
⚠️ High Risk
FEI: 3030820300 • Mexico City • MEXICO
FEI Number
3030820300
Location
Mexico City
Country
MEXICOAddress
130 Real Mayorazgo Ave, , Mexico City, , Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2024 | 61EDR11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GLAXOSMITHKLINE MEXICO SA DE CV's FDA import refusal history?
GLAXOSMITHKLINE MEXICO SA DE CV (FEI: 3030820300) has 1 FDA import refusal record(s) in our database, spanning from 6/13/2024 to 6/13/2024.
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 MEXICO SA DE CV's FEI number is 3030820300.
What types of violations has GLAXOSMITHKLINE MEXICO SA DE CV received?
GLAXOSMITHKLINE MEXICO SA DE CV 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 MEXICO SA DE CV come from?
All FDA import refusal data for GLAXOSMITHKLINE MEXICO SA DE CV 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.