GlaxoWellcome Production
⚠️ High Risk
FEI: 3002807436 • Evreux, Eure • FRANCE
FEI Number
3002807436
Location
Evreux, Eure
Country
FRANCEAddress
Zone Industrielle 2, 23 Rue Lavoisier, Evreux, Eure, France
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2024 | 63BDR01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/24/2024 | 60WCB01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 12/8/2020 | 63BCC01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2020 | 63BCY02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/26/2019 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/1/2017 | 63BDY02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 3/26/2012 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/27/2011 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/2/2008 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | San Francisco District Office (SAN-DO) | |
| 9/13/2005 | 60SAP99ANTACID, N.E.C. | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 61EDV11SALMETEROL XINAFOATE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/7/2002 | 64HDL99EXPECTORANT N.E.C. | Florida District Office (FLA-DO) | |
| 11/21/2001 | 64HDL99EXPECTORANT N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is GlaxoWellcome Production's FDA import refusal history?
GlaxoWellcome Production (FEI: 3002807436) has 13 FDA import refusal record(s) in our database, spanning from 11/21/2001 to 11/21/2024.
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. GlaxoWellcome Production's FEI number is 3002807436.
What types of violations has GlaxoWellcome Production received?
GlaxoWellcome Production 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 GlaxoWellcome Production come from?
All FDA import refusal data for GlaxoWellcome Production 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.