GLAXOSMITHKLINE
⚠️ High Risk
FEI: 3021212279 • Mississauga, Ontario • CANADA
FEI Number
3021212279
Location
Mississauga, Ontario
Country
CANADAAddress
100 Milverton Dr, , Mississauga, Ontario, Canada
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2025 | 63BDQ99BRONCHODILATOR N.E.C. | Division of Southeast Imports (DSEI) | |
| 11/14/2025 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 72NEW VET DR | Division of Southeast Imports (DSEI) |
| 2/18/2025 | 58MCY20BELIMUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2024 | 64FCA99ENZYME INHIBITOR N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/20/2024 | 62VCA42VALACYCLOVIR HCL (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2024 | 63BDQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GLAXOSMITHKLINE's FDA import refusal history?
GLAXOSMITHKLINE (FEI: 3021212279) has 6 FDA import refusal record(s) in our database, spanning from 1/31/2024 to 12/12/2025.
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's FEI number is 3021212279.
What types of violations has GLAXOSMITHKLINE received?
GLAXOSMITHKLINE has been cited for 4 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.