Baxter Productos Medicos, Ltda.
⚠️ Moderate Risk
FEI: 3002806588 • Cartago • COSTA RICA
FEI Number
3002806588
Location
Cartago
Country
COSTA RICAAddress
Parque Industrial - De Cartago, Apartado No. 1-7052, Cartago, , 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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).
INVDEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a device for investigational use for which no exemption has been granted as prescribed by Section 520(g)
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2021 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/22/2021 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/22/2021 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/22/2021 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/22/2021 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/18/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/18/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/18/2019 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/18/2019 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/18/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/18/2019 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/18/2019 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/20/2018 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/20/2018 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/20/2018 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 12/20/2018 | 80BRZSET, BLOOD TRANSFUSION | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/1/2014 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Division of Southeast Imports (DSEI) | |
| 8/21/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 2380NO PMA/PDP | San Juan District Office (SJN-DO) |
| 8/21/2012 | 80NEPSYSTEM/DEVICE, PHARMACY COMPOUNDING | 2380NO PMA/PDP | San Juan District Office (SJN-DO) |
| 8/21/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 2380NO PMA/PDP | San Juan District Office (SJN-DO) |
| 8/21/2012 | 80BRZSET, BLOOD TRANSFUSION | 2380NO PMA/PDP | San Juan District Office (SJN-DO) |
| 8/21/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 2380NO PMA/PDP | San Juan District Office (SJN-DO) |
| 8/21/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 2380NO PMA/PDP | San Juan District Office (SJN-DO) |
| 8/21/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 2380NO PMA/PDP | San Juan District Office (SJN-DO) |
| 8/21/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 2380NO PMA/PDP | San Juan District Office (SJN-DO) |
| 8/21/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 237NO PMA | San Juan District Office (SJN-DO) |
| 8/21/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 237NO PMA | San Juan District Office (SJN-DO) |
| 8/6/2012 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 3081INVDEVICE | San Juan District Office (SJN-DO) |
| 8/6/2012 | 78LJHSYSTEM, IRRIGATION, UROLOGICAL | 2380NO PMA/PDP | San Juan District Office (SJN-DO) |
| 12/9/2008 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Baxter Productos Medicos, Ltda.'s FDA import refusal history?
Baxter Productos Medicos, Ltda. (FEI: 3002806588) has 30 FDA import refusal record(s) in our database, spanning from 12/9/2008 to 1/22/2021.
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. Baxter Productos Medicos, Ltda.'s FEI number is 3002806588.
What types of violations has Baxter Productos Medicos, Ltda. received?
Baxter Productos Medicos, Ltda. 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 Baxter Productos Medicos, Ltda. come from?
All FDA import refusal data for Baxter Productos Medicos, Ltda. 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.