DANYANG WISHFUL OPTICAL CO., LTD.
⚠️ Moderate Risk
FEI: 3006897872 • Zhenjiang • CHINA
FEI Number
3006897872
Location
Zhenjiang
Country
CHINAAddress
194 ZHONGSHAN RD, YUNYANG TOWN DANYANG, , Zhenjiang, , 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
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 |
|---|---|---|---|
| 11/10/2015 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/24/2012 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Seattle District Office (SEA-DO) | |
| 5/24/2012 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is DANYANG WISHFUL OPTICAL CO., LTD.'s FDA import refusal history?
DANYANG WISHFUL OPTICAL CO., LTD. (FEI: 3006897872) has 3 FDA import refusal record(s) in our database, spanning from 5/24/2012 to 11/10/2015.
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. DANYANG WISHFUL OPTICAL CO., LTD.'s FEI number is 3006897872.
What types of violations has DANYANG WISHFUL OPTICAL CO., LTD. received?
DANYANG WISHFUL 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 DANYANG WISHFUL OPTICAL CO., LTD. come from?
All FDA import refusal data for DANYANG WISHFUL 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.