Abbott Vascular Costa Rica (AVCR)
⚠️ Moderate Risk
FEI: 3009564766 • Alajuela, Alajuela • COSTA RICA
FEI Number
3009564766
Location
Alajuela, Alajuela
Country
COSTA RICAAddress
52 Calle 3, B31 Coyol Free Zone, Calle 3, Coyol Free Zone 52, El Coyol, Alajuela, Alajuela, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/21/2022 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/6/2015 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/6/2015 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/6/2015 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/6/2015 | 74LOXCATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS & OPERATIVE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Abbott Vascular Costa Rica (AVCR)'s FDA import refusal history?
Abbott Vascular Costa Rica (AVCR) (FEI: 3009564766) has 5 FDA import refusal record(s) in our database, spanning from 5/6/2015 to 7/21/2022.
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 Vascular Costa Rica (AVCR)'s FEI number is 3009564766.
What types of violations has Abbott Vascular Costa Rica (AVCR) received?
Abbott Vascular Costa Rica (AVCR) has been cited for 2 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 Vascular Costa Rica (AVCR) come from?
All FDA import refusal data for Abbott Vascular Costa Rica (AVCR) 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.