Wenzhou Xinda Optics Co Ltd
⚠️ Moderate Risk
FEI: 3009417631 • Wenzhou • CHINA
FEI Number
3009417631
Location
Wenzhou
Country
CHINAAddress
Room 2105 Building E Zhannan Commercial, , Wenzhou, , China
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 Wenzhou Xinda Optics Co Ltd's FDA import refusal history?
Wenzhou Xinda Optics Co Ltd (FEI: 3009417631) has 2 FDA import refusal record(s) in our database, spanning from 6/29/2012 to 6/29/2012.
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 Xinda Optics Co Ltd's FEI number is 3009417631.
What types of violations has Wenzhou Xinda Optics Co Ltd received?
Wenzhou Xinda Optics Co 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 Wenzhou Xinda Optics Co Ltd come from?
All FDA import refusal data for Wenzhou Xinda Optics 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.