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NI TECHNOLOGY

⚠️ Moderate Risk

FEI: 3017104224 • Santa Catarina • MEXICO

FEI

FEI Number

3017104224

📍

Location

Santa Catarina

🇲🇽

Country

MEXICO
🏢

Address

Helio 420 Parque Indsut, , Santa Catarina, , Mexico

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/27/2020
Latest Refusal
10/27/2020
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
10/27/2020
80QLBDECONTAMINATION SYSTEMS FOR GLOVES, GOWNS, AND OTHER APPAREL EXCLUDING MASKS, RESPIRATORS, FACE SHIE
508NO 510(K)
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is NI TECHNOLOGY's FDA import refusal history?

NI TECHNOLOGY (FEI: 3017104224) has 1 FDA import refusal record(s) in our database, spanning from 10/27/2020 to 10/27/2020.

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. NI TECHNOLOGY's FEI number is 3017104224.

What types of violations has NI TECHNOLOGY received?

NI TECHNOLOGY 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 NI TECHNOLOGY come from?

All FDA import refusal data for NI TECHNOLOGY 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.