Arthrocare Corporation
⚠️ High Risk
FEI: 3012358417 • Coyol, Alajuela • COSTA RICA
FEI Number
3012358417
Location
Coyol, Alajuela
Country
COSTA RICAAddress
B32.1, St2 , Zona Franca Coyol, 625 Calle. Zona Franca Coyol de Alajuela Edificio B 32, Coyol, Alajuela, Costa Rica
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
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.
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).
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 |
|---|---|---|---|
| 1/9/2024 | 87LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 1/9/2024 | 79GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE | 3280FRNMFGREG | Division of Southwest Imports (DSWI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 10/27/2023 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 11/25/2022 | 87HTWBIT, DRILL | Division of Southeast Imports (DSEI) | |
| 11/25/2022 | 87HTWBIT, DRILL | Division of Southeast Imports (DSEI) | |
| 11/25/2022 | 87HTWBIT, DRILL | Division of Southeast Imports (DSEI) | |
| 11/25/2022 | 87HTWBIT, DRILL | Division of Southeast Imports (DSEI) | |
| 7/5/2022 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Arthrocare Corporation's FDA import refusal history?
Arthrocare Corporation (FEI: 3012358417) has 45 FDA import refusal record(s) in our database, spanning from 7/5/2022 to 1/9/2024.
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. Arthrocare Corporation's FEI number is 3012358417.
What types of violations has Arthrocare Corporation received?
Arthrocare Corporation 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 Arthrocare Corporation come from?
All FDA import refusal data for Arthrocare Corporation 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.