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Laboratorios Demac Ltda

⚠️ Moderate Risk

FEI: 3010803089 • Bogota • COLOMBIA

FEI

FEI Number

3010803089

📍

Location

Bogota

🇨🇴

Country

COLOMBIA
🏢

Address

Carrera 81 B No 8a-37, , Bogota, , Colombia

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/20/2011
Latest Refusal
10/20/2011
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

DateProductViolationsDivision
10/20/2011
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Laboratorios Demac Ltda's FDA import refusal history?

Laboratorios Demac Ltda (FEI: 3010803089) has 1 FDA import refusal record(s) in our database, spanning from 10/20/2011 to 10/20/2011.

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. Laboratorios Demac Ltda's FEI number is 3010803089.

What types of violations has Laboratorios Demac Ltda received?

Laboratorios Demac Ltda 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 Laboratorios Demac Ltda come from?

All FDA import refusal data for Laboratorios Demac 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.