Glaxosmithkline Mexico, S.A. De C.V.
⚠️ Moderate Risk
FEI: 3003597306 • Mexico, Distrito Federal • MEXICO
FEI Number
3003597306
Location
Mexico, Distrito Federal
Country
MEXICOAddress
Calzada Mexico-Xochimilco # 4900san, , Mexico, Distrito Federal, 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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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 |
|---|---|---|---|
| 4/29/2016 | 56CCA72CEFUROXIME SODIUM (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/26/2016 | 61XBY45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC) | Division of Southeast Imports (DSEI) | |
| 12/13/2011 | 60WCK01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 60WCA01ALBENDAZOLE (ANTHELMINTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/29/2006 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 56CBC71CEFUROXIME AXETIL (CEPHALOSPORINS) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/8/2004 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 1/8/2004 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
| 1/8/2004 | 53LC06MOISTURIZING (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Glaxosmithkline Mexico, S.A. De C.V.'s FDA import refusal history?
Glaxosmithkline Mexico, S.A. De C.V. (FEI: 3003597306) has 9 FDA import refusal record(s) in our database, spanning from 1/8/2004 to 4/29/2016.
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 Mexico, S.A. De C.V.'s FEI number is 3003597306.
What types of violations has Glaxosmithkline Mexico, S.A. De C.V. received?
Glaxosmithkline Mexico, S.A. De C.V. 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 Mexico, S.A. De C.V. come from?
All FDA import refusal data for Glaxosmithkline 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.