GlaxoSmithKline LLC
⚠️ High Risk
FEI: 1033964 • Zebulon, NC • UNITED STATES
FEI Number
1033964
Location
Zebulon, NC
Country
UNITED STATESAddress
1011 N Arendell Ave, , Zebulon, NC, United States
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/17/2025 | 61EDV99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 61ECY99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/2/2019 | 63BDZ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2017 | 61NCA05BUPROPION HCL (ANTI-DEPRESSANT) | 179AGR RX | Division of Southeast Imports (DSEI) |
| 8/24/2011 | 61PCA31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/24/2011 | 61PCA31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/17/2006 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/17/2006 | 62OCA22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/16/2006 | 61TCP28ONDANSETRON HYDROCHLORIDE (ANTI-EMETIC/NAUSEANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/16/2006 | 62LCA44ATOVAQUONE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/16/2006 | 61MCA38LAMOTRIGINE (ANTI-CONVULSANT) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is GlaxoSmithKline LLC's FDA import refusal history?
GlaxoSmithKline LLC (FEI: 1033964) has 11 FDA import refusal record(s) in our database, spanning from 7/16/2006 to 11/17/2025.
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 LLC's FEI number is 1033964.
What types of violations has GlaxoSmithKline LLC received?
GlaxoSmithKline LLC has been cited for 2 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 LLC come from?
All FDA import refusal data for GlaxoSmithKline LLC 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.