Universal Technology
⚠️ Moderate Risk
FEI: 1000638517 • Newcastle, Nevis • SAINT KITTS AND NEVIS
FEI Number
1000638517
Location
Newcastle, Nevis
Country
SAINT KITTS AND NEVISAddress
Newcastle,Nevis, , Newcastle, Nevis, Saint Kitts and Nevis
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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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 Universal Technology's FDA import refusal history?
Universal Technology (FEI: 1000638517) has 2 FDA import refusal record(s) in our database, spanning from 7/2/2008 to 7/2/2008.
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. Universal Technology's FEI number is 1000638517.
What types of violations has Universal Technology received?
Universal Technology 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 Universal Technology come from?
All FDA import refusal data for Universal Technology 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.