World Electronic Shen Zhen Co. Ltd
⚠️ Moderate Risk
FEI: 3004800725 • Guangdong • CHINA
FEI Number
3004800725
Location
Guangdong
Country
CHINAAddress
No 273 Shenshan Road, , 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/25/2005 | 91DKCALCOHOL CONTROL MATERIALS | 508NO 510(K) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is World Electronic Shen Zhen Co. Ltd's FDA import refusal history?
World Electronic Shen Zhen Co. Ltd (FEI: 3004800725) has 1 FDA import refusal record(s) in our database, spanning from 1/25/2005 to 1/25/2005.
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. World Electronic Shen Zhen Co. Ltd's FEI number is 3004800725.
What types of violations has World Electronic Shen Zhen Co. Ltd received?
World Electronic Shen Zhen Co. Ltd has been cited for 1 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 World Electronic Shen Zhen Co. Ltd come from?
All FDA import refusal data for World Electronic Shen Zhen 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.