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CYNOSURE

⚠️ Moderate Risk

FEI: 3012849651 • Villaviciosa de Odon, Madrid • SPAIN

FEI

FEI Number

3012849651

📍

Location

Villaviciosa de Odon, Madrid

🇪🇸

Country

SPAIN
🏢

Address

Avenida Quitapesares N 17, , Villaviciosa de Odon, Madrid, Spain

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
4/3/2017
Latest Refusal
4/3/2017
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4761×

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

DateProductViolationsDivision
4/3/2017
95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL
476NO REGISTR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CYNOSURE's FDA import refusal history?

CYNOSURE (FEI: 3012849651) has 1 FDA import refusal record(s) in our database, spanning from 4/3/2017 to 4/3/2017.

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. CYNOSURE's FEI number is 3012849651.

What types of violations has CYNOSURE received?

CYNOSURE 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 CYNOSURE come from?

All FDA import refusal data for CYNOSURE 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.