LINHAISHI WANDA GLASSES FACTORY
⚠️ High Risk
FEI: 3013436056 • LINHAI, ZHEJIANG • CHINA
FEI Number
3013436056
Location
LINHAI, ZHEJIANG
Country
CHINAAddress
FENDONG VILLAGE DAFEN, DUQIAO, LINHAI, ZHEJIANG, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
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.
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 |
|---|---|---|---|
| 12/31/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/31/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/31/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/31/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/5/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HOYSHIELD, EYE, OPHTHALMIC (INCLUDING SUNLAMP PROTECTIVE EYEWEAR AND POST-MYDRIATIC EYEWEAR) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 12/4/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 11/10/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 11/10/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 11/10/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 11/10/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 11/10/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 11/10/2025 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of West Coast Imports (DWCI) | |
| 10/20/2025 | 86HOISPECTACLE, MAGNIFYING | Division of West Coast Imports (DWCI) | |
| 8/4/2022 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 6/28/2021 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 12/7/2020 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LINHAISHI WANDA GLASSES FACTORY's FDA import refusal history?
LINHAISHI WANDA GLASSES FACTORY (FEI: 3013436056) has 69 FDA import refusal record(s) in our database, spanning from 12/7/2020 to 12/31/2025.
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. LINHAISHI WANDA GLASSES FACTORY's FEI number is 3013436056.
What types of violations has LINHAISHI WANDA GLASSES FACTORY received?
LINHAISHI WANDA GLASSES FACTORY has been cited for 4 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 LINHAISHI WANDA GLASSES FACTORY come from?
All FDA import refusal data for LINHAISHI WANDA GLASSES FACTORY 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.