Wenzhou Lucheng East Optical Fac
✅ Low Risk
FEI: 3005325805 • Wenzhou • CHINA
FEI Number
3005325805
Location
Wenzhou
Country
CHINAAddress
19 Dezhen Road E,Niuashan Road N, , Wenzhou, , 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/2/2009 | 86HOISPECTACLE, MAGNIFYING | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Wenzhou Lucheng East Optical Fac's FDA import refusal history?
Wenzhou Lucheng East Optical Fac (FEI: 3005325805) has 1 FDA import refusal record(s) in our database, spanning from 2/2/2009 to 2/2/2009.
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. Wenzhou Lucheng East Optical Fac's FEI number is 3005325805.
What types of violations has Wenzhou Lucheng East Optical Fac received?
Wenzhou Lucheng East Optical Fac 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 Wenzhou Lucheng East Optical Fac come from?
All FDA import refusal data for Wenzhou Lucheng East Optical Fac 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.