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Confecciones Salome Ltda

⚠️ Moderate Risk

FEI: 3006697280 • Cali • COLOMBIA

FEI

FEI Number

3006697280

📍

Location

Cali

🇨🇴

Country

COLOMBIA
🏢

Address

Carrera 23D No. 13-37, , Cali, , Colombia

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/26/2020
Latest Refusal
4/26/2020
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
4/26/2020
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
2280DIRSEXMPT
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Confecciones Salome Ltda's FDA import refusal history?

Confecciones Salome Ltda (FEI: 3006697280) has 1 FDA import refusal record(s) in our database, spanning from 4/26/2020 to 4/26/2020.

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. Confecciones Salome Ltda's FEI number is 3006697280.

What types of violations has Confecciones Salome Ltda received?

Confecciones Salome Ltda 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 Confecciones Salome Ltda come from?

All FDA import refusal data for Confecciones Salome Ltda 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.