Sopracolle
⚠️ Moderate Risk
FEI: 3006561110 • Tambe Bl • ITALY
FEI Number
3006561110
Location
Tambe Bl
Country
ITALYAddress
1-32010 Perazolo Di Cadore, , Tambe Bl, , 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
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/28/2012 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | 235NOT IMPACT | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Sopracolle's FDA import refusal history?
Sopracolle (FEI: 3006561110) has 1 FDA import refusal record(s) in our database, spanning from 9/28/2012 to 9/28/2012.
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. Sopracolle's FEI number is 3006561110.
What types of violations has Sopracolle received?
Sopracolle 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 Sopracolle come from?
All FDA import refusal data for Sopracolle 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.