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Productos Quimicos Monterrey, Sa

⚠️ High Risk

FEI: 3009002540 • Monterrey, Nl • MEXICO

FEI

FEI Number

3009002540

📍

Location

Monterrey, Nl

🇲🇽

Country

MEXICO
🏢

Address

Mirador, , Monterrey, Nl, Mexico

High Risk

FDA Import Risk Assessment

53.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/15/2025
Latest Refusal
5/15/2025
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
86.9×20%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
5/15/2025
63UIY01POTASSIUM NITRATE
27DRUG GMPS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Productos Quimicos Monterrey, Sa's FDA import refusal history?

Productos Quimicos Monterrey, Sa (FEI: 3009002540) has 1 FDA import refusal record(s) in our database, spanning from 5/15/2025 to 5/15/2025.

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 Quimicos Monterrey, Sa's FEI number is 3009002540.

What types of violations has Productos Quimicos Monterrey, Sa received?

Productos Quimicos Monterrey, Sa 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 Productos Quimicos Monterrey, Sa come from?

All FDA import refusal data for Productos Quimicos Monterrey, Sa 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.