Glaxo Wellcome S.A.
⚠️ High Risk
FEI: 3004195227 • Aranda De Duero, Burgos • SPAIN
FEI Number
3004195227
Location
Aranda De Duero, Burgos
Country
SPAINAddress
Avenida De Extremadura 3, , Aranda De Duero, Burgos, Spain
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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/22/2023 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/14/2021 | 62VDA42VALACYCLOVIR HCL (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/5/2021 | 63BCZ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2020 | 63BAQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/2/2019 | 77KCOINHALER, NASAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/30/2019 | 63BCY99BRONCHODILATOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2018 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/9/2018 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2018 | 61XCL50AZELASTINE HYDROCHLORIDE/FLUTICASONE, ANTI-HISTAMINE STEROID (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2016 | 61ECQ99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/24/2016 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/27/2016 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/4/2011 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/30/2009 | 61XCP99ANTI-HISTAMINIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2006 | 63BCW99BRONCHODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/1/2006 | 63CBQ01BARIUM HYDROXIDE LIME (CARBON DIOXIDE ABSORBANT) | 331DR QUALITC | Baltimore District Office (BLT-DO) |
| 11/1/2006 | 63CBQ01BARIUM HYDROXIDE LIME (CARBON DIOXIDE ABSORBANT) | 331DR QUALITC | Baltimore District Office (BLT-DO) |
| 2/16/2006 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 115DR QUALITY | Baltimore District Office (BLT-DO) |
| 4/22/2004 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 115DR QUALITY | Baltimore District Office (BLT-DO) |
| 12/5/2003 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 115DR QUALITY | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is Glaxo Wellcome S.A.'s FDA import refusal history?
Glaxo Wellcome S.A. (FEI: 3004195227) has 20 FDA import refusal record(s) in our database, spanning from 12/5/2003 to 10/22/2023.
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 Wellcome S.A.'s FEI number is 3004195227.
What types of violations has Glaxo Wellcome S.A. received?
Glaxo Wellcome S.A. 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 Glaxo Wellcome S.A. come from?
All FDA import refusal data for Glaxo Wellcome S.A. 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.