Wenzhou Guixin Optical Co Ltd
⚠️ Moderate Risk
FEI: 3016422768 • Wenzhou, Zhejiang • CHINA
FEI Number
3016422768
Location
Wenzhou, Zhejiang
Country
CHINAAddress
Longwan 9 Dong Yangalou Fl 4, Hao 4 Yongxing Street, 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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
Frequently Asked Questions
What is Wenzhou Guixin Optical Co Ltd's FDA import refusal history?
Wenzhou Guixin Optical Co Ltd (FEI: 3016422768) has 1 FDA import refusal record(s) in our database, spanning from 11/19/2024 to 11/19/2024.
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 Guixin Optical Co Ltd's FEI number is 3016422768.
What types of violations has Wenzhou Guixin Optical Co Ltd received?
Wenzhou Guixin Optical Co Ltd has been cited for 3 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 Guixin Optical Co Ltd come from?
All FDA import refusal data for Wenzhou Guixin 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.