Boyuan Shoes Factory
✅ Low Risk
FEI: 3011016993 • Dong Guan City • CHINA
FEI Number
3011016993
Location
Dong Guan City
Country
CHINAAddress
No 1 Yong Tai East Road Shan Mei Xin, , Dong Guan City, , China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/14/2014 | 89IPGSHOE, CAST | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Boyuan Shoes Factory's FDA import refusal history?
Boyuan Shoes Factory (FEI: 3011016993) has 1 FDA import refusal record(s) in our database, spanning from 11/14/2014 to 11/14/2014.
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. Boyuan Shoes Factory's FEI number is 3011016993.
What types of violations has Boyuan Shoes Factory received?
Boyuan Shoes Factory 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 Boyuan Shoes Factory come from?
All FDA import refusal data for Boyuan Shoes 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.