Glaxosmithkline Argentina S.A.
⚠️ High Risk
FEI: 3019602300 • Unknown • ARGENTINA
FEI Number
3019602300
Location
Unknown
Country
ARGENTINAAddress
Carlos Casares 3690, , Unknown, , Argentina
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
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.
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).
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 |
|---|---|---|---|
| 8/27/2025 | 65RBC18SODIUM BICARBONATE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 8/27/2025 | 65RBC18SODIUM BICARBONATE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 6/7/2022 | 62GAY99ANTI-INFLAMMATORY N.E.C. | Division of Southeast Imports (DSEI) | |
| 6/2/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 6/1/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 6/1/2022 | 62GDJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/31/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/23/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/20/2022 | 62GBB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/17/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 62GBJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 62GBJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/15/2022 | 62GCJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/10/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/9/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/5/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/5/2022 | 62GBB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/5/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 5/4/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/30/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/30/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/30/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/30/2022 | 62GAO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/30/2022 | 62GAO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/30/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/29/2022 | 62GCO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/28/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/28/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/28/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/28/2022 | 62GBO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/28/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/27/2022 | 62GAO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/27/2022 | 62GBJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/27/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/27/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/27/2022 | 62GBJ90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/27/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 4/27/2022 | 62GAY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2022 | 62GAO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2022 | 62GAO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/27/2022 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/20/2022 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/25/2019 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2006 | 62GCF41IBUPROFEN (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/24/2005 | 66VCP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Glaxosmithkline Argentina S.A.'s FDA import refusal history?
Glaxosmithkline Argentina S.A. (FEI: 3019602300) has 63 FDA import refusal record(s) in our database, spanning from 10/24/2005 to 8/27/2025.
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 Argentina S.A.'s FEI number is 3019602300.
What types of violations has Glaxosmithkline Argentina S.A. received?
Glaxosmithkline Argentina S.A. has been cited for 4 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 Argentina S.A. come from?
All FDA import refusal data for Glaxosmithkline Argentina S.A. 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.