Horizons International Corporation
⚠️ Moderate Risk
FEI: 3004083736 • La Valencia Heredia, Heredia • COSTA RICA
FEI Number
3004083736
Location
La Valencia Heredia, Heredia
Country
COSTA RICAAddress
Zeta Free Zone Park, , La Valencia Heredia, 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.
Refusal History
Frequently Asked Questions
What is Horizons International Corporation's FDA import refusal history?
Horizons International Corporation (FEI: 3004083736) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2011 to 12/13/2011.
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. Horizons International Corporation's FEI number is 3004083736.
What types of violations has Horizons International Corporation received?
Horizons International Corporation 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 Horizons International Corporation come from?
All FDA import refusal data for Horizons International 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.