Glaxo Smithkline Mexico S.A. De C.V.
⚠️ Moderate Risk
FEI: 3003699513 • Del Tlalpan Mexico D.F. • MEXICO
FEI Number
3003699513
Location
Del Tlalpan Mexico D.F.
Country
MEXICOAddress
Calzada Mexico Xochimilco # 4900, Col. San, Del Tlalpan Mexico D.F., , Mexico
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2019 | 56CCA71CEFUROXIME AXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/27/2010 | 53IA99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/25/2010 | 53IA99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 10/30/2008 | 64LDY67CLOBETASOL PROPIONATE (GLUCOCORTICOID) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 10/28/2008 | 56CYC71CEFUROXIME AXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 2/11/2008 | 56CDA27CEPHALEXIN (CEPHALOSPORINS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/8/2007 | 62GCA49NAPROXEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/8/2007 | 66TCA01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Glaxo Smithkline Mexico S.A. De C.V.'s FDA import refusal history?
Glaxo Smithkline Mexico S.A. De C.V. (FEI: 3003699513) has 8 FDA import refusal record(s) in our database, spanning from 11/8/2007 to 3/14/2019.
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 Smithkline Mexico S.A. De C.V.'s FEI number is 3003699513.
What types of violations has Glaxo Smithkline Mexico S.A. De C.V. received?
Glaxo Smithkline Mexico S.A. De C.V. 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 Smithkline Mexico S.A. De C.V. come from?
All FDA import refusal data for Glaxo Smithkline Mexico S.A. De C.V. 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.