Laboratoire Glaxo Smith Kline
⚠️ Moderate Risk
FEI: 3004374867 • Marly Le Roi, Yvelines • FRANCE
FEI Number
3004374867
Location
Marly Le Roi, Yvelines
Country
FRANCEAddress
100 Route De Versailles, , Marly Le Roi, Yvelines, France
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/3/2008 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/3/2008 | 56BDB03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/7/2006 | 60SAA25RANITIDINE HYDROCHLORIDE (ANTACID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/14/2005 | 63BCQ99BRONCHODILATOR N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/14/2004 | 62VCA32LAMIVUDINE (ANTI-VIRAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratoire Glaxo Smith Kline's FDA import refusal history?
Laboratoire Glaxo Smith Kline (FEI: 3004374867) has 5 FDA import refusal record(s) in our database, spanning from 4/14/2004 to 9/3/2008.
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. Laboratoire Glaxo Smith Kline's FEI number is 3004374867.
What types of violations has Laboratoire Glaxo Smith Kline received?
Laboratoire Glaxo Smith Kline has been cited for 1 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 Laboratoire Glaxo Smith Kline come from?
All FDA import refusal data for Laboratoire Glaxo Smith Kline 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.