Increase Benefit Optical Mfy Ltd
⚠️ Moderate Risk
FEI: 3008258909 • Dong Guandong Guan • CHINA
FEI Number
3008258909
Location
Dong Guandong Guan
Country
CHINAAddress
Wah Fung Optical Co Ltdhng Tonb In Zone, , Dong Guandong Guan, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/5/2013 | 86HQZFRAME, SPECTACLE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/5/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 11/5/2013 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Increase Benefit Optical Mfy Ltd's FDA import refusal history?
Increase Benefit Optical Mfy Ltd (FEI: 3008258909) has 3 FDA import refusal record(s) in our database, spanning from 11/5/2013 to 11/5/2013.
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. Increase Benefit Optical Mfy Ltd's FEI number is 3008258909.
What types of violations has Increase Benefit Optical Mfy Ltd received?
Increase Benefit Optical Mfy Ltd 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 Increase Benefit Optical Mfy Ltd come from?
All FDA import refusal data for Increase Benefit Optical Mfy 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.