YIWU DISHUO SUNGLASSES CO. LTD
⚠️ Moderate Risk
FEI: 3013886197 • Zhejiang • CHINA
FEI Number
3013886197
Location
Zhejiang
Country
CHINAAddress
808 Floor 8 A2 No 588 C, , Zhejiang, , 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 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.
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
Frequently Asked Questions
What is YIWU DISHUO SUNGLASSES CO. LTD's FDA import refusal history?
YIWU DISHUO SUNGLASSES CO. LTD (FEI: 3013886197) has 1 FDA import refusal record(s) in our database, spanning from 11/3/2017 to 11/3/2017.
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. YIWU DISHUO SUNGLASSES CO. LTD's FEI number is 3013886197.
What types of violations has YIWU DISHUO SUNGLASSES CO. LTD received?
YIWU DISHUO SUNGLASSES CO. LTD 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 YIWU DISHUO SUNGLASSES CO. LTD come from?
All FDA import refusal data for YIWU DISHUO SUNGLASSES 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.