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DIRECTSALUD

✅ Low Risk

FEI: 3012745345 • Barcelona, Barcelona • SPAIN

FEI

FEI Number

3012745345

📍

Location

Barcelona, Barcelona

🇪🇸

Country

SPAIN
🏢

Address

Travessera de Dalt 17 1, , Barcelona, Barcelona, Spain

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
9/30/2016
Latest Refusal
9/30/2016
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
9/30/2016
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is DIRECTSALUD's FDA import refusal history?

DIRECTSALUD (FEI: 3012745345) has 1 FDA import refusal record(s) in our database, spanning from 9/30/2016 to 9/30/2016.

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. DIRECTSALUD's FEI number is 3012745345.

What types of violations has DIRECTSALUD received?

DIRECTSALUD 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 DIRECTSALUD come from?

All FDA import refusal data for DIRECTSALUD 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.