VIANT COSTA RICA, S.A.
⚠️ Moderate Risk
FEI: 3005173255 • Barreal De Heredia • COSTA RICA
FEI Number
3005173255
Location
Barreal De Heredia
Country
COSTA RICAAddress
Metropolitana Edificio 2c, Parque Zona Franca, Edificio 2c, Barreal De Heredia, , 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 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.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/24/2023 | 80FOZCATHETER, INTRAVASCULAR, SHORT TERM | 78STERILITY | Division of Northern Border Imports (DNBI) |
| 10/17/2009 | 73BSPNEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | 508NO 510(K) | New Orleans District Office (NOL-DO) |
| 5/7/2006 | 79KDDKIT, SURGICAL INSTRUMENT, DISPOSABLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is VIANT COSTA RICA, S.A.'s FDA import refusal history?
VIANT COSTA RICA, S.A. (FEI: 3005173255) has 3 FDA import refusal record(s) in our database, spanning from 5/7/2006 to 5/24/2023.
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. VIANT COSTA RICA, S.A.'s FEI number is 3005173255.
What types of violations has VIANT COSTA RICA, S.A. received?
VIANT COSTA RICA, S.A. 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 VIANT COSTA RICA, S.A. come from?
All FDA import refusal data for VIANT COSTA RICA, S.A. 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.