Glaxosmithkline
⚠️ Moderate Risk
FEI: 3008320249 • Uxbridge, Middlesex • UNITED KINGDOM
FEI Number
3008320249
Location
Uxbridge, Middlesex
Country
UNITED KINGDOMAddress
West, Uxbridge, 1 Iron Bridge Road, Uxbridge, Middlesex, United Kingdom
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).
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 |
|---|---|---|---|
| 4/28/2020 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2019 | 61NDB05BUPROPION HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/16/2017 | 63BCQ99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2015 | 61EDY11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/6/2015 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/13/2012 | 61MCB38LAMOTRIGINE (ANTI-CONVULSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/4/2011 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/7/2007 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 11/8/2005 | 61ECA99ANTI-ASTHMATIC, N.E.C. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/31/2004 | 64LDO08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Glaxosmithkline's FDA import refusal history?
Glaxosmithkline (FEI: 3008320249) has 10 FDA import refusal record(s) in our database, spanning from 8/31/2004 to 4/28/2020.
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 3008320249.
What types of violations has Glaxosmithkline received?
Glaxosmithkline 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 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.