Zhongshan City Newwish Metal & Electronical Factory
⚠️ Moderate Risk
FEI: 3004763524 • Zhongshan City • CHINA
FEI Number
3004763524
Location
Zhongshan City
Country
CHINAAddress
3, Rd Industrial Zone Tan Zhou Town, Zhongshan 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/6/2008 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 8/6/2008 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 8/6/2008 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 8/6/2008 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) | |
| 8/6/2008 | 95RESLASER POINTER, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Zhongshan City Newwish Metal & Electronical Factory's FDA import refusal history?
Zhongshan City Newwish Metal & Electronical Factory (FEI: 3004763524) has 5 FDA import refusal record(s) in our database, spanning from 8/6/2008 to 8/6/2008.
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 City Newwish Metal & Electronical Factory's FEI number is 3004763524.
What types of violations has Zhongshan City Newwish Metal & Electronical Factory received?
Zhongshan City Newwish Metal & Electronical Factory has been cited for 2 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 City Newwish Metal & Electronical Factory come from?
All FDA import refusal data for Zhongshan City Newwish Metal & Electronical 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.