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Ros'S Estetical Sl

✅ Low Risk

FEI: 3007926653 • Castelldefels, Barcelona • SPAIN

FEI

FEI Number

3007926653

📍

Location

Castelldefels, Barcelona

🇪🇸

Country

SPAIN
🏢

Address

C Del Molinot 46-48, , Castelldefels, Barcelona, Spain

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
7/26/2017
Latest Refusal
7/26/2017
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
7/26/2017
79OUHSKIN RESURFACING RF APPLICATOR
118NOT LISTED
473LABELING
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Ros'S Estetical Sl's FDA import refusal history?

Ros'S Estetical Sl (FEI: 3007926653) has 1 FDA import refusal record(s) in our database, spanning from 7/26/2017 to 7/26/2017.

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. Ros'S Estetical Sl's FEI number is 3007926653.

What types of violations has Ros'S Estetical Sl received?

Ros'S Estetical Sl has been cited for 2 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 Ros'S Estetical Sl come from?

All FDA import refusal data for Ros'S Estetical Sl 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.