Nexo Srl
✅ Low Risk
FEI: 3007478333 • Calalzo di Cadore, Belluno • ITALY
FEI Number
3007478333
Location
Calalzo di Cadore, Belluno
Country
ITALYAddress
Via Marmarole 20, , Calalzo di Cadore, Belluno, 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 |
|---|---|---|---|
| 2/20/2013 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Nexo Srl's FDA import refusal history?
Nexo Srl (FEI: 3007478333) has 1 FDA import refusal record(s) in our database, spanning from 2/20/2013 to 2/20/2013.
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. Nexo Srl's FEI number is 3007478333.
What types of violations has Nexo Srl received?
Nexo Srl 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 Nexo Srl come from?
All FDA import refusal data for Nexo Srl 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.