Wenzhou Sunzone Optical Co.,Ltd.
✅ Low Risk
FEI: 3009316007 • Wenzhou, Zhejiang • CHINA
FEI Number
3009316007
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Room 203, 19 Wutian Subdistrict Lincun Cun; Ouhai District, Wenzhou, Zhejiang, 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
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 Wenzhou Sunzone Optical Co.,Ltd.'s FDA import refusal history?
Wenzhou Sunzone Optical Co.,Ltd. (FEI: 3009316007) has 1 FDA import refusal record(s) in our database, spanning from 2/3/2012 to 2/3/2012.
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 Sunzone Optical Co.,Ltd.'s FEI number is 3009316007.
What types of violations has Wenzhou Sunzone Optical Co.,Ltd. received?
Wenzhou Sunzone Optical Co.,Ltd. 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 Wenzhou Sunzone Optical Co.,Ltd. come from?
All FDA import refusal data for Wenzhou Sunzone Optical Co.,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.