Dongguan Fenggang Yantian Gaoxing Glasses
⚠️ Moderate Risk
FEI: 3008062144 • Feng Gang • 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 IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2015 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 235NOT IMPACT | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Dongguan Fenggang Yantian Gaoxing Glasses's FDA import refusal history?
Dongguan Fenggang Yantian Gaoxing Glasses (FEI: 3008062144) has 1 FDA import refusal record(s) in our database, spanning from 5/21/2015 to 5/21/2015.
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. Dongguan Fenggang Yantian Gaoxing Glasses's FEI number is 3008062144.
What types of violations has Dongguan Fenggang Yantian Gaoxing Glasses received?
Dongguan Fenggang Yantian Gaoxing Glasses 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 Dongguan Fenggang Yantian Gaoxing Glasses come from?
All FDA import refusal data for Dongguan Fenggang Yantian Gaoxing Glasses 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.