New Stetic
✅ Low Risk
FEI: 3008987905 • Guarne • COLOMBIA
FEI Number
3008987905
Location
Guarne
Country
COLOMBIAAddress
Ant. Medellin Bogota Km 22, , Guarne, , Colombia
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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 |
|---|---|---|---|
| 4/9/2020 | 76EJJALLOY, AMALGAM | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is New Stetic's FDA import refusal history?
New Stetic (FEI: 3008987905) has 1 FDA import refusal record(s) in our database, spanning from 4/9/2020 to 4/9/2020.
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. New Stetic's FEI number is 3008987905.
What types of violations has New Stetic received?
New Stetic has been cited for 1 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 New Stetic come from?
All FDA import refusal data for New Stetic 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.