Fortune Optical Su Zhou Industry Co Ltd
⚠️ Moderate Risk
FEI: 3006237758 • Wujiang City • CHINA
FEI Number
3006237758
Location
Wujiang City
Country
CHINAAddress
Zhenze Town, Ming Gang Road West Ba Du Industry Zone, Wujiang City, , 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/1/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 4/1/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 4/1/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 4/1/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 4/1/2016 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Southwest Import District Office (SWI-DO) |
| 8/22/2014 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Fortune Optical Su Zhou Industry Co Ltd's FDA import refusal history?
Fortune Optical Su Zhou Industry Co Ltd (FEI: 3006237758) has 6 FDA import refusal record(s) in our database, spanning from 8/22/2014 to 4/1/2016.
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. Fortune Optical Su Zhou Industry Co Ltd's FEI number is 3006237758.
What types of violations has Fortune Optical Su Zhou Industry Co Ltd received?
Fortune Optical Su Zhou Industry Co 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 Fortune Optical Su Zhou Industry Co Ltd come from?
All FDA import refusal data for Fortune Optical Su Zhou Industry 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.