Shenzhen Winner Co., Ltd.
⚠️ Moderate Risk
FEI: 3001094111 • Shenzhen • CHINA
FEI Number
3001094111
Location
Shenzhen
Country
CHINAAddress
Block B Billow Terrance Seacove Garden, , Shenzhen, , 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 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 |
|---|---|---|---|
| 10/7/2005 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 10/7/2005 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
| 10/7/2005 | 95L31CD PLAYERS (COMPACT DISC PLAYERS) | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shenzhen Winner Co., Ltd.'s FDA import refusal history?
Shenzhen Winner Co., Ltd. (FEI: 3001094111) has 3 FDA import refusal record(s) in our database, spanning from 10/7/2005 to 10/7/2005.
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. Shenzhen Winner Co., Ltd.'s FEI number is 3001094111.
What types of violations has Shenzhen Winner Co., Ltd. received?
Shenzhen Winner 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 Shenzhen Winner Co., Ltd. come from?
All FDA import refusal data for Shenzhen Winner 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.