Glaxo Smith Kline
⚠️ Moderate Risk
FEI: 3005413344 • Riyadhriyadh • SAUDI ARABIA
FEI Number
3005413344
Location
Riyadhriyadh
Country
SAUDI ARABIAAddress
309 Al Mohdar, , Riyadhriyadh, , Saudi Arabia
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 |
|---|---|---|---|
| 8/9/2011 | 64LIS67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Minneapolis District Office (MIN-DO) | |
| 8/9/2011 | 64LCS08BETAMETHASONE VALERATE (GLUCOCORTICOID) | Minneapolis District Office (MIN-DO) | |
| 1/22/2009 | 60DDO99ADRENOCORTICAL STEROID N.E.C. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 5/2/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/2/2008 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/13/2007 | 64LDJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 8/13/2007 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2007 | 64LCJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/13/2007 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/2/2006 | 62FAJ99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 11/2/2006 | 64LAJ99GLUCOCORTICOID N.E.C. | 75UNAPPROVED | New England District Office (NWE-DO) |
| 5/1/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Glaxo Smith Kline's FDA import refusal history?
Glaxo Smith Kline (FEI: 3005413344) has 12 FDA import refusal record(s) in our database, spanning from 5/1/2006 to 8/9/2011.
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 Smith Kline's FEI number is 3005413344.
What types of violations has Glaxo Smith Kline received?
Glaxo Smith Kline has been cited for 2 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 Smith Kline come from?
All FDA import refusal data for 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.