GlaxoSmithKline LLC
⚠️ High Risk
FEI: 1035048 • Durham, NC • UNITED STATES
FEI Number
1035048
Location
Durham, NC
Country
UNITED STATESAddress
410 Blackwell St, , Durham, NC, United States
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).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
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 |
|---|---|---|---|
| 6/17/2024 | 64LAJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2020 | 63BCQ01ALBUTEROL (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/15/2020 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 6/2/2020 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/31/2019 | 61EDY99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/16/2018 | 64UDY08DUTASTERIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/4/2017 | 61MDA38LAMOTRIGINE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2017 | 61MCA38LAMOTRIGINE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/4/2015 | 61NDY77PAROXETINE HCL (ANTI-DEPRESSANT) | 179AGR RX | Division of Northern Border Imports (DNBI) |
| 12/2/2015 | 63BCQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 179AGR RX | Atlanta District Office (ATL-DO) |
| 2/7/2014 | 63BIQ25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 179AGR RX | New York District Office (NYK-DO) |
| 8/20/2012 | 57CH02INFLUENZA VIRUS VACCINE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/20/2012 | 63BAL25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/20/2009 | 63BCQ02ALBUTEROL SULFATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/17/2007 | 63BDK25FLUTICASONE PROPIONATE (BRONCHODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/18/2006 | 62LCP99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 179AGR RX | New Orleans District Office (NOL-DO) |
| 9/15/2005 | 62OQY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/22/2005 | 62LIB44ATOVAQUONE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 2/17/2005 | 60LCA89SUMATRIPTAN SUCCINATE (ANALGESIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is GlaxoSmithKline LLC's FDA import refusal history?
GlaxoSmithKline LLC (FEI: 1035048) has 20 FDA import refusal record(s) in our database, spanning from 2/17/2005 to 6/17/2024.
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. GlaxoSmithKline LLC's FEI number is 1035048.
What types of violations has GlaxoSmithKline LLC received?
GlaxoSmithKline LLC 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 GlaxoSmithKline LLC come from?
All FDA import refusal data for GlaxoSmithKline LLC 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.