Wenzhou Ouqi Electronic Co. Ltd
⚠️ Moderate Risk
FEI: 3011601793 • Wenzhou City • CHINA
FEI Number
3011601793
Location
Wenzhou City
Country
CHINAAddress
Xiafeng Village, Shuangchao Lucheng District, Wenzhou City, , 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
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.
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.
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 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2016 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 1/25/2016 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 1/25/2016 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 10/28/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | New England District Office (NWE-DO) |
| 10/28/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | New England District Office (NWE-DO) |
| 10/28/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | New England District Office (NWE-DO) |
| 10/9/2014 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 278NO TAG | Chicago District Office (CHI-DO) |
| 7/25/2014 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Chicago District Office (CHI-DO) |
| 7/30/2013 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 336INCONSPICU | Los Angeles District Office (LOS-DO) |
| 7/30/2013 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 336INCONSPICU | Los Angeles District Office (LOS-DO) |
| 7/30/2013 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 336INCONSPICU | Los Angeles District Office (LOS-DO) |
| 11/7/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Seattle District Office (SEA-DO) | |
| 12/30/2010 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | New York District Office (NYK-DO) | |
| 9/7/2010 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | Los Angeles District Office (LOS-DO) | |
| 9/7/2010 | 95REJTOY, NOVELTY, PLAY LASER PRODUCT | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Wenzhou Ouqi Electronic Co. Ltd's FDA import refusal history?
Wenzhou Ouqi Electronic Co. Ltd (FEI: 3011601793) has 15 FDA import refusal record(s) in our database, spanning from 9/7/2010 to 7/24/2016.
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 Ouqi Electronic Co. Ltd's FEI number is 3011601793.
What types of violations has Wenzhou Ouqi Electronic Co. Ltd received?
Wenzhou Ouqi 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 Wenzhou Ouqi Electronic Co. Ltd come from?
All FDA import refusal data for Wenzhou Ouqi 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.