Safilo Far East Ltd
✅ Low Risk
FEI: 3005611559 • Hong Kong • CHINA
FEI Number
3005611559
Location
Hong Kong
Country
CHINAAddress
52 Floor The Centre 99 Queen Rd, , Hong Kong, , China
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
Frequently Asked Questions
What is Safilo Far East Ltd's FDA import refusal history?
Safilo Far East Ltd (FEI: 3005611559) has 2 FDA import refusal record(s) in our database, spanning from 4/24/2006 to 4/24/2006.
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. Safilo Far East Ltd's FEI number is 3005611559.
What types of violations has Safilo Far East Ltd received?
Safilo Far East Ltd 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 Safilo Far East Ltd come from?
All FDA import refusal data for Safilo Far East Ltd 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.