Wenzhou Xinke Electric Co. Ltd
⚠️ Moderate Risk
FEI: 3005026322 • Wenzhou • CHINA
FEI Number
3005026322
Location
Wenzhou
Country
CHINAAddress
No 39-4 Tu Tian Road, Tu Tian Industrial, Zhe Jiang, Wenzhou, , 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
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.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/21/2016 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | New Orleans District Office (NOL-DO) | |
| 10/18/2011 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Chicago District Office (CHI-DO) | |
| 5/25/2011 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 5/25/2011 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 5/25/2011 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 5/25/2011 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 5/25/2011 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 5/25/2011 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 5/25/2011 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 5/25/2011 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Southwest Import District Office (SWI-DO) | |
| 5/25/2011 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Southwest Import District Office (SWI-DO) | |
| 7/24/2007 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 7/24/2007 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 7/24/2007 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 7/24/2007 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 7/24/2007 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 10/6/2006 | 95L29LASER LIGHT SHOW | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Wenzhou Xinke Electric Co. Ltd's FDA import refusal history?
Wenzhou Xinke Electric Co. Ltd (FEI: 3005026322) has 17 FDA import refusal record(s) in our database, spanning from 10/6/2006 to 6/21/2016.
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. Wenzhou Xinke Electric Co. Ltd's FEI number is 3005026322.
What types of violations has Wenzhou Xinke Electric Co. Ltd received?
Wenzhou Xinke Electric Co. Ltd has been cited for 7 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 Wenzhou Xinke Electric Co. Ltd come from?
All FDA import refusal data for Wenzhou Xinke Electric 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.