Technic Star Universal
✅ Low Risk
FEI: 3004526354 • Kowloon • HONG KONG
FEI Number
3004526354
Location
Kowloon
Country
HONG KONGAddress
Limited Room 1013 Hung To Road, Road No. 1 Kwun Tong, Kowloon, , Hong Kong
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
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).
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
Frequently Asked Questions
What is Technic Star Universal's FDA import refusal history?
Technic Star Universal (FEI: 3004526354) has 2 FDA import refusal record(s) in our database, spanning from 5/14/2009 to 5/14/2009.
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. Technic Star Universal's FEI number is 3004526354.
What types of violations has Technic Star Universal received?
Technic Star Universal 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 Technic Star Universal come from?
All FDA import refusal data for Technic Star Universal 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.