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HTM HIGH TECH MECANICAL SA DE CV

✅ Low Risk

FEI: 3014421273 • San Nicolas De Los Garza, Nuevo Leon • MEXICO

FEI

FEI Number

3014421273

📍

Location

San Nicolas De Los Garza, Nuevo Leon

🇲🇽

Country

MEXICO
🏢

Address

Calle Puerto La Paz 508, Col. La Fe, San Nicolas De Los Garza, San Nicolas De Los Garza, Nuevo Leon, Mexico

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
9/21/2018
Latest Refusal
9/21/2018
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
9/21/2018
73KFZHUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HTM HIGH TECH MECANICAL SA DE CV's FDA import refusal history?

HTM HIGH TECH MECANICAL SA DE CV (FEI: 3014421273) has 1 FDA import refusal record(s) in our database, spanning from 9/21/2018 to 9/21/2018.

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. HTM HIGH TECH MECANICAL SA DE CV's FEI number is 3014421273.

What types of violations has HTM HIGH TECH MECANICAL SA DE CV received?

HTM HIGH TECH MECANICAL 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 HTM HIGH TECH MECANICAL SA DE CV come from?

All FDA import refusal data for HTM HIGH TECH MECANICAL 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.