Jiaxing Luya Leather Co
✅ Low Risk
FEI: 3010436092 • Jia Xing, Zhejiang • CHINA
FEI Number
3010436092
Location
Jia Xing, Zhejiang
Country
CHINAAddress
No 153 Furunnan Road, Nanhu District, Jia Xing, Zhejiang, 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 |
|---|---|---|---|
| 12/6/2013 | 79LRRKIT, FIRST AID | 341REGISTERED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Jiaxing Luya Leather Co's FDA import refusal history?
Jiaxing Luya Leather Co (FEI: 3010436092) has 1 FDA import refusal record(s) in our database, spanning from 12/6/2013 to 12/6/2013.
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. Jiaxing Luya Leather Co's FEI number is 3010436092.
What types of violations has Jiaxing Luya Leather Co received?
Jiaxing Luya Leather Co 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 Jiaxing Luya Leather Co come from?
All FDA import refusal data for Jiaxing Luya Leather Co 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.