Zhongshan Eletech Metals Elec Factory
⚠️ Moderate Risk
FEI: 3006166358 • Guangdong • CHINA
FEI Number
3006166358
Location
Guangdong
Country
CHINAAddress
Jiahua Road Quianlong Industrial Zone, Sanxiang Town, Zhongshan City, Guangdong, , 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.
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.
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.
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 |
|---|---|---|---|
| 8/6/2014 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 278NO TAG | Los Angeles District Office (LOS-DO) |
| 8/6/2014 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 278NO TAG | Los Angeles District Office (LOS-DO) |
| 8/6/2014 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 278NO TAG | Los Angeles District Office (LOS-DO) |
| 8/6/2014 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 9/27/2012 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Los Angeles District Office (LOS-DO) |
| 12/30/2010 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 1/28/2010 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Los Angeles District Office (LOS-DO) |
| 11/3/2009 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Los Angeles District Office (LOS-DO) |
| 7/15/2009 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 126FAILS STD | Los Angeles District Office (LOS-DO) |
| 7/15/2009 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Los Angeles District Office (LOS-DO) |
| 7/8/2009 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 47NON STD | Southwest Import District Office (SWI-DO) |
| 6/22/2009 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Zhongshan Eletech Metals Elec Factory's FDA import refusal history?
Zhongshan Eletech Metals Elec Factory (FEI: 3006166358) has 32 FDA import refusal record(s) in our database, spanning from 6/22/2009 to 8/6/2014.
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. Zhongshan Eletech Metals Elec Factory's FEI number is 3006166358.
What types of violations has Zhongshan Eletech Metals Elec Factory received?
Zhongshan Eletech Metals Elec Factory 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 Zhongshan Eletech Metals Elec Factory come from?
All FDA import refusal data for Zhongshan Eletech Metals Elec 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.