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PRODUCTOS GIZEH SA DE CV

⚠️ High Risk

FEI: 3036498503 • Zalpopan • MEXICO

FEI

FEI Number

3036498503

📍

Location

Zalpopan

🇲🇽

Country

MEXICO
🏢

Address

Pedro Ramirez No. 5, Col. Hogares del Batan, , Zalpopan, , Mexico

High Risk

FDA Import Risk Assessment

57.3
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
2
Unique Violations
4/9/2025
Latest Refusal
4/9/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
84.6×20%
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).

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
4/9/2025
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
197COSM COLOR
75UNAPPROVED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is PRODUCTOS GIZEH SA DE CV's FDA import refusal history?

PRODUCTOS GIZEH SA DE CV (FEI: 3036498503) has 1 FDA import refusal record(s) in our database, spanning from 4/9/2025 to 4/9/2025.

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. PRODUCTOS GIZEH SA DE CV's FEI number is 3036498503.

What types of violations has PRODUCTOS GIZEH SA DE CV received?

PRODUCTOS GIZEH SA 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 PRODUCTOS GIZEH SA DE CV come from?

All FDA import refusal data for PRODUCTOS GIZEH SA 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.