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Quimica Pumex Sa De Cv

⚠️ Moderate Risk

FEI: 3011934825 • San Pedro Garza Garcia, Nuevo Leon • MEXICO

FEI

FEI Number

3011934825

📍

Location

San Pedro Garza Garcia, Nuevo Leon

🇲🇽

Country

MEXICO
🏢

Address

Libramiento Noroeste Km. 12.8 Veranda, , San Pedro Garza Garcia, Nuevo Leon, Mexico

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/4/2020
Latest Refusal
12/4/2020
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

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
12/4/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Quimica Pumex Sa De Cv's FDA import refusal history?

Quimica Pumex Sa De Cv (FEI: 3011934825) has 1 FDA import refusal record(s) in our database, spanning from 12/4/2020 to 12/4/2020.

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. Quimica Pumex Sa De Cv's FEI number is 3011934825.

What types of violations has Quimica Pumex Sa De Cv received?

Quimica Pumex 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 Quimica Pumex Sa De Cv come from?

All FDA import refusal data for Quimica Pumex 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.