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Tecnoglobal PH7, SA de CV

⚠️ High Risk

FEI: 3012937159 • Zapopan, Jalisco • MEXICO

FEI

FEI Number

3012937159

📍

Location

Zapopan, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Avenida El Tigre 2140, Col. Los Robles, Zapopan, Jalisco, Mexico

High Risk

FDA Import Risk Assessment

57.5
LowModerateHighCritical

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

Statistics

17
Total Refusals
1
Unique Violations
6/9/2021
Latest Refusal
3/5/2021
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
46.5×30%
Recency
7.7×20%
Frequency
100.0×10%
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

2717×

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
6/9/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
6/9/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
6/9/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/24/2021
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/24/2021
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)
3/5/2021
62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL)
27DRUG GMPS
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is Tecnoglobal PH7, SA de CV's FDA import refusal history?

Tecnoglobal PH7, SA de CV (FEI: 3012937159) has 17 FDA import refusal record(s) in our database, spanning from 3/5/2021 to 6/9/2021.

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. Tecnoglobal PH7, SA de CV's FEI number is 3012937159.

What types of violations has Tecnoglobal PH7, SA de CV received?

Tecnoglobal PH7, 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 Tecnoglobal PH7, SA de CV come from?

All FDA import refusal data for Tecnoglobal PH7, 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.