Abbott Medical Costa Rica Ltda
⚠️ Moderate Risk
FEI: 3008452825 • Alajuela, El Coyol • COSTA RICA
FEI Number
3008452825
Location
Alajuela, El Coyol
Country
COSTA RICAAddress
Abbott Electrophysiology Unit, Zona Franca Coyol, Edificio #44, Calle 0 Ave 2, Alajuela, El Coyol, 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).
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).
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)
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/16/2018 | 74MLVDEVICE, TRANSCATHETER CARDIAC OCCLUSION | 3081INVDEVICE | Division of Northern Border Imports (DNBI) |
| 3/26/2015 | 74OADCATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER | Minneapolis District Office (MIN-DO) | |
| 11/3/2014 | 84GXIPROBE, RADIOFREQUENCY LESION | 508NO 510(K) | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Abbott Medical Costa Rica Ltda's FDA import refusal history?
Abbott Medical Costa Rica Ltda (FEI: 3008452825) has 3 FDA import refusal record(s) in our database, spanning from 11/3/2014 to 11/16/2018.
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. Abbott Medical Costa Rica Ltda's FEI number is 3008452825.
What types of violations has Abbott Medical Costa Rica Ltda received?
Abbott Medical Costa Rica Ltda 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 Abbott Medical Costa Rica Ltda come from?
All FDA import refusal data for Abbott Medical Costa Rica 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.