Glaxo Saudi Arabia Ltd.
⚠️ Moderate Risk
FEI: 3002624237 • Unknown • SAUDI ARABIA
FEI Number
3002624237
Location
Unknown
Country
SAUDI ARABIAAddress
Unknown, , Unknown, , 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).
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 |
|---|---|---|---|
| 9/28/2017 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 7/18/2013 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 5/16/2013 | 64LCJ03BETAMETHASONE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 5/16/2013 | 64LCJ03BETAMETHASONE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 5/3/2013 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/2/2013 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/20/2012 | 64LDJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/20/2012 | 64LAO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/17/2012 | 66YDY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/29/2012 | 66YCJ99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/22/2012 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 12/13/2011 | 64LDO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New Orleans District Office (NOL-DO) | |
| 12/5/2011 | 64LCJ08BETAMETHASONE VALERATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/5/2011 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/19/2010 | 64LCJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | Detroit District Office (DET-DO) | |
| 8/27/2010 | 64LDJ67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New England District Office (NWE-DO) | |
| 1/5/2010 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 2/9/2009 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 4/9/2008 | 64LCO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/5/2006 | 66VDJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 12/30/2003 | 64LDO67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 1/4/2002 | 66BIY99STIMULANT N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Glaxo Saudi Arabia Ltd.'s FDA import refusal history?
Glaxo Saudi Arabia Ltd. (FEI: 3002624237) has 22 FDA import refusal record(s) in our database, spanning from 1/4/2002 to 9/28/2017.
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 Saudi Arabia Ltd.'s FEI number is 3002624237.
What types of violations has Glaxo Saudi Arabia Ltd. received?
Glaxo Saudi Arabia Ltd. has been cited for 6 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 Saudi Arabia Ltd. come from?
All FDA import refusal data for Glaxo Saudi Arabia 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.