Glaxo Smith Kline UK
⚠️ High Risk
FEI: 3000263379 • Greenford • UNITED KINGDOM
FEI Number
3000263379
Location
Greenford
Country
UNITED KINGDOMAddress
889 Greenford Road, , Greenford, , United Kingdom
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/6/2013 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/6/2013 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/6/2013 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 11/6/2013 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 10/22/2013 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 10/22/2013 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 10/22/2013 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 10/2/2013 | 64LAJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Los Angeles District Office (LOS-DO) | |
| 6/20/2012 | 64LCO03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/7/2012 | 64LDO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/10/2011 | 63BCY25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2009 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2009 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/29/2008 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Glaxo Smith Kline UK's FDA import refusal history?
Glaxo Smith Kline UK (FEI: 3000263379) has 15 FDA import refusal record(s) in our database, spanning from 4/29/2008 to 11/6/2013.
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. Glaxo Smith Kline UK's FEI number is 3000263379.
What types of violations has Glaxo Smith Kline UK received?
Glaxo Smith Kline UK has been cited for 3 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 Glaxo Smith Kline UK come from?
All FDA import refusal data for Glaxo Smith Kline UK 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.