Glaxo Operations U.K. Ltd.
⚠️ High Risk
FEI: 3002807078 • Barnard Castle, County Durham • UNITED KINGDOM
FEI Number
3002807078
Location
Barnard Castle, County Durham
Country
UNITED KINGDOMAddress
Harmire Road, , Barnard Castle, County Durham, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2025 | 58MCY20BELIMUMAB | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/3/2025 | 58MCY20BELIMUMAB | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/23/2025 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2024 | 64LDO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2024 | 56CDA72CEFUROXIME SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 11/9/2022 | 56CCY71CEFUROXIME AXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/26/2019 | 56BCY03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/30/2017 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 473LABELING | Division of Northeast Imports (DNEI) |
| 5/11/2016 | 56ICA76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/18/2013 | 66BAY44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/11/2012 | 64LAJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/10/2010 | 62VCY17ABACAVIR SULFATE (ANTI-VIRAL) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/9/2008 | 80KZHINTRODUCER, SYRINGE NEEDLE | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 8/7/2007 | 66YDJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | New York District Office (NYK-DO) | |
| 7/25/2006 | 61MCS38LAMOTRIGINE (ANTI-CONVULSANT) | New York District Office (NYK-DO) | |
| 5/2/2005 | 62OCS22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | New York District Office (NYK-DO) | |
| 5/2/2005 | 62OCS22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | New York District Office (NYK-DO) | |
| 3/23/2005 | 64LAY08BETAMETHASONE VALERATE (GLUCOCORTICOID) | San Francisco District Office (SAN-DO) | |
| 3/23/2005 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | San Francisco District Office (SAN-DO) | |
| 2/24/2005 | 63BCS25FLUTICASONE PROPIONATE (BRONCHODILATOR) | New York District Office (NYK-DO) | |
| 2/24/2005 | 61ECS12ZAFIRLUKAST (ANTI-ASTHMATIC) | New York District Office (NYK-DO) | |
| 9/29/2004 | 64LIP56PREDNISONE (GLUCOCORTICOID) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/9/2004 | 64XIS06SALICYLIC ACID (KERATOLYTIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Glaxo Operations U.K. Ltd.'s FDA import refusal history?
Glaxo Operations U.K. Ltd. (FEI: 3002807078) has 23 FDA import refusal record(s) in our database, spanning from 9/9/2004 to 9/3/2025.
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. Glaxo Operations U.K. Ltd.'s FEI number is 3002807078.
What types of violations has Glaxo Operations U.K. Ltd. received?
Glaxo Operations U.K. Ltd. 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 Operations U.K. Ltd. come from?
All FDA import refusal data for Glaxo Operations U.K. Ltd. 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.