Wenzhou Brightlook Optical Co Ltd
⚠️ Moderate Risk
FEI: 3008620140 • Wenzhoushi, Zhejiangsheng • CHINA
FEI Number
3008620140
Location
Wenzhoushi, Zhejiangsheng
Country
CHINAAddress
Rm 1605 E Zhannan Trading Bldgwutian Rd, , Wenzhoushi, Zhejiangsheng, 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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
Frequently Asked Questions
What is Wenzhou Brightlook Optical Co Ltd's FDA import refusal history?
Wenzhou Brightlook Optical Co Ltd (FEI: 3008620140) has 2 FDA import refusal record(s) in our database, spanning from 12/9/2011 to 12/12/2011.
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. Wenzhou Brightlook Optical Co Ltd's FEI number is 3008620140.
What types of violations has Wenzhou Brightlook Optical Co Ltd received?
Wenzhou Brightlook 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 Brightlook Optical Co Ltd come from?
All FDA import refusal data for Wenzhou Brightlook 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.