New Leather Line
✅ Low Risk
FEI: 3004521829 • Caleppio Di Settala Mi • ITALY
FEI Number
3004521829
Location
Caleppio Di Settala Mi
Country
ITALYAddress
Via Garibaldi 3, , Caleppio Di Settala Mi, , Italy
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 |
|---|---|---|---|
| 11/3/2004 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is New Leather Line's FDA import refusal history?
New Leather Line (FEI: 3004521829) has 1 FDA import refusal record(s) in our database, spanning from 11/3/2004 to 11/3/2004.
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. New Leather Line's FEI number is 3004521829.
What types of violations has New Leather Line received?
New Leather Line 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 New Leather Line come from?
All FDA import refusal data for New Leather Line 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.