Safilo Spa
⚠️ Moderate Risk
FEI: 3004066212 • Pieve di Cadore, Belluno • ITALY
FEI Number
3004066212
Location
Pieve di Cadore, Belluno
Country
ITALYAddress
Piazza Tiziano 8, , Pieve di Cadore, Belluno, Italy
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
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 |
|---|---|---|---|
| 5/29/2008 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/29/2008 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/29/2008 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/29/2008 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 5/29/2008 | 86HQZFRAME, SPECTACLE | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Safilo Spa's FDA import refusal history?
Safilo Spa (FEI: 3004066212) has 5 FDA import refusal record(s) in our database, spanning from 5/29/2008 to 5/29/2008.
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. Safilo Spa's FEI number is 3004066212.
What types of violations has Safilo Spa received?
Safilo Spa 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 Safilo Spa come from?
All FDA import refusal data for Safilo Spa 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.