Win Dragon Limited
⚠️ Moderate Risk
FEI: 1000534966 • Kowloon • HONG KONG
FEI Number
1000534966
Location
Kowloon
Country
HONG KONGAddress
33 Ashley Road, Rm 607 Kowloon Ctr, Kowloon, , Hong Kong
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).
Refusal History
Frequently Asked Questions
What is Win Dragon Limited's FDA import refusal history?
Win Dragon Limited (FEI: 1000534966) has 2 FDA import refusal record(s) in our database, spanning from 2/11/2011 to 2/11/2011.
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. Win Dragon Limited's FEI number is 1000534966.
What types of violations has Win Dragon Limited received?
Win Dragon Limited 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 Win Dragon Limited come from?
All FDA import refusal data for Win Dragon Limited 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.