Zhejiang Wenzhou Sheng Wei Electronic Co Ltd
⚠️ Moderate Risk
FEI: 3006979695 • Linjiang Town Wenzhouzhejiang • CHINA
FEI Number
3006979695
Location
Linjiang Town Wenzhouzhejiang
Country
CHINAAddress
69 Jinsheng Roadjinao Village, , Linjiang Town Wenzhouzhejiang, , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
NO TAG
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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/5/2009 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Southwest Import District Office (SWI-DO) | |
| 1/5/2009 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 1/5/2009 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Zhejiang Wenzhou Sheng Wei Electronic Co Ltd's FDA import refusal history?
Zhejiang Wenzhou Sheng Wei Electronic Co Ltd (FEI: 3006979695) has 3 FDA import refusal record(s) in our database, spanning from 1/5/2009 to 3/5/2009.
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. Zhejiang Wenzhou Sheng Wei Electronic Co Ltd's FEI number is 3006979695.
What types of violations has Zhejiang Wenzhou Sheng Wei Electronic Co Ltd received?
Zhejiang Wenzhou Sheng Wei Electronic Co Ltd has been cited for 5 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 Zhejiang Wenzhou Sheng Wei Electronic Co Ltd come from?
All FDA import refusal data for Zhejiang Wenzhou Sheng Wei Electronic 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.