Bri Optilas Spa
⚠️ Moderate Risk
FEI: 3003494845 • Milano, MI • 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/31/2002 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | 476NO REGISTR | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Bri Optilas Spa's FDA import refusal history?
Bri Optilas Spa (FEI: 3003494845) has 1 FDA import refusal record(s) in our database, spanning from 1/31/2002 to 1/31/2002.
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. Bri Optilas Spa's FEI number is 3003494845.
What types of violations has Bri Optilas Spa received?
Bri Optilas 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 Bri Optilas Spa come from?
All FDA import refusal data for Bri Optilas 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.