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INDUSTRIA QUIMICO FARMACEUTICAS AMERICANAS SA DE CV

⚠️ High Risk

FEI: 3017555274 • LERMA • MEXICO

FEI

FEI Number

3017555274

📍

Location

LERMA

🇲🇽

Country

MEXICO
🏢

Address

CIRCUITO CERILLO II MZA 1, LOTE 17 COL. PARQUE INDUSTRIAL, LERMA, , Mexico

High Risk

FDA Import Risk Assessment

52.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/22/2023
Latest Refusal
12/22/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
58.4×20%
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

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
12/22/2023
62KCY10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is INDUSTRIA QUIMICO FARMACEUTICAS AMERICANAS SA DE CV's FDA import refusal history?

INDUSTRIA QUIMICO FARMACEUTICAS AMERICANAS SA DE CV (FEI: 3017555274) has 1 FDA import refusal record(s) in our database, spanning from 12/22/2023 to 12/22/2023.

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. INDUSTRIA QUIMICO FARMACEUTICAS AMERICANAS SA DE CV's FEI number is 3017555274.

What types of violations has INDUSTRIA QUIMICO FARMACEUTICAS AMERICANAS SA DE CV received?

INDUSTRIA QUIMICO FARMACEUTICAS AMERICANAS SA DE CV 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 INDUSTRIA QUIMICO FARMACEUTICAS AMERICANAS SA DE CV come from?

All FDA import refusal data for INDUSTRIA QUIMICO FARMACEUTICAS AMERICANAS 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.