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Macrolab Associates Ltda

✅ Low Risk

FEI: 3004468900 • Medellin, Antioquia • COLOMBIA

FEI

FEI Number

3004468900

📍

Location

Medellin, Antioquia

🇨🇴

Country

COLOMBIA
🏢

Address

Cra 48no, Calle 48 75 152; LOC, Medellin, Antioquia, Colombia

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
2
Unique Violations
5/3/2016
Latest Refusal
5/3/2016
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.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
5/3/2016
53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS)
471CSTIC LBLG
475COSMETLBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Macrolab Associates Ltda's FDA import refusal history?

Macrolab Associates Ltda (FEI: 3004468900) has 1 FDA import refusal record(s) in our database, spanning from 5/3/2016 to 5/3/2016.

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. Macrolab Associates Ltda's FEI number is 3004468900.

What types of violations has Macrolab Associates Ltda received?

Macrolab Associates 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 Macrolab Associates Ltda come from?

All FDA import refusal data for Macrolab Associates 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.