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Genomma Lab Internacional SAB de CV

⚠️ Moderate Risk

FEI: 3010336046 • Mexico City • MEXICO

FEI

FEI Number

3010336046

📍

Location

Mexico City

🇲🇽

Country

MEXICO
🏢

Address

Antonio Doval Jaime # 70 Piso 2, Santa Fe, Ivaro, Mexico City, , Mexico

Moderate Risk

FDA Import Risk Assessment

30.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/24/2017
Latest Refusal
11/24/2017
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
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).

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
11/24/2017
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
197COSM COLOR
471CSTIC LBLG
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Genomma Lab Internacional SAB de CV's FDA import refusal history?

Genomma Lab Internacional SAB de CV (FEI: 3010336046) has 1 FDA import refusal record(s) in our database, spanning from 11/24/2017 to 11/24/2017.

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. Genomma Lab Internacional SAB de CV's FEI number is 3010336046.

What types of violations has Genomma Lab Internacional SAB de CV received?

Genomma Lab Internacional SAB de CV 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 Genomma Lab Internacional SAB de CV come from?

All FDA import refusal data for Genomma Lab Internacional SAB de CV 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.