Wenzhou Red Star Optical Co. Ltd.
⚠️ Moderate Risk
FEI: 3003911088 • Wenzhou, Zhejiang • CHINA
FEI Number
3003911088
Location
Wenzhou, Zhejiang
Country
CHINAAddress
E Zhongxing Bldg 11, Xincheng Avenue, Wenzhou, Zhejiang, 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).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
Frequently Asked Questions
What is Wenzhou Red Star Optical Co. Ltd.'s FDA import refusal history?
Wenzhou Red Star Optical Co. Ltd. (FEI: 3003911088) has 1 FDA import refusal record(s) in our database, spanning from 9/14/2012 to 9/14/2012.
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 Red Star Optical Co. Ltd.'s FEI number is 3003911088.
What types of violations has Wenzhou Red Star Optical Co. Ltd. received?
Wenzhou Red Star 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 Red Star Optical Co. Ltd. come from?
All FDA import refusal data for Wenzhou Red Star 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.