Vision Optical Technology
⚠️ Moderate Risk
FEI: 3010229692 • Jiangsu • 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
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/8/2015 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 3280FRNMFGREG | Los Angeles District Office (LOS-DO) |
| 9/8/2015 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | 3280FRNMFGREG | Los Angeles District Office (LOS-DO) |
| 9/8/2015 | 86HQZFRAME, SPECTACLE | 3280FRNMFGREG | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Vision Optical Technology's FDA import refusal history?
Vision Optical Technology (FEI: 3010229692) has 3 FDA import refusal record(s) in our database, spanning from 9/8/2015 to 9/8/2015.
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. Vision Optical Technology's FEI number is 3010229692.
What types of violations has Vision Optical Technology received?
Vision Optical Technology 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 Vision Optical Technology come from?
All FDA import refusal data for Vision Optical Technology 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.