GlaxoSmithKline Costa Rica SA
⚠️ Moderate Risk
FEI: 3006551280 • San Jose, San Jose • COSTA RICA
FEI Number
3006551280
Location
San Jose, San Jose
Country
COSTA RICAAddress
Este de Rotonda de la Bandera 500, Carretera a Sabanilla, San Jose, San Jose, Costa Rica
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
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).
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2017 | 60SBR99ANTACID, N.E.C. | Division of Northeast Imports (DNEI) | |
| 5/13/2016 | 65RBR18SODIUM BICARBONATE (REPLENISHER) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 4/1/2016 | 60LAA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 4/18/2014 | 65RBY18SODIUM BICARBONATE (REPLENISHER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/1/2013 | 65RAR18SODIUM BICARBONATE (REPLENISHER) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 11/27/2012 | 65RAR18SODIUM BICARBONATE (REPLENISHER) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/23/2012 | 65RAR18SODIUM BICARBONATE (REPLENISHER) | Division of Southeast Imports (DSEI) | |
| 6/10/2008 | 62MBJ08MENTHOL (ANTI-PRURITIC) | Florida District Office (FLA-DO) | |
| 6/10/2008 | 62MBJ08MENTHOL (ANTI-PRURITIC) | Florida District Office (FLA-DO) | |
| 7/11/2006 | 60SBB09DIHYDROXYALUM SODIUM CARBONATE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/19/2004 | 60SAY11MAGNESIA (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/19/2004 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/3/2004 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/29/2004 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/29/2004 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/26/2004 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 9/18/2003 | 60SAY11MAGNESIA (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/8/2003 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/15/2003 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/25/2003 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/15/2003 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/30/2003 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 4/3/2003 | 60SAY11MAGNESIA (ANTACID) | 118NOT LISTED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is GlaxoSmithKline Costa Rica SA's FDA import refusal history?
GlaxoSmithKline Costa Rica SA (FEI: 3006551280) has 24 FDA import refusal record(s) in our database, spanning from 4/3/2003 to 4/20/2017.
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. GlaxoSmithKline Costa Rica SA's FEI number is 3006551280.
What types of violations has GlaxoSmithKline Costa Rica SA received?
GlaxoSmithKline Costa Rica SA has been cited for 5 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 Costa Rica SA come from?
All FDA import refusal data for GlaxoSmithKline Costa Rica SA 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.