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Hi Tec Implants Ltd

⚠️ Moderate Risk

FEI: 3006598352 • Herzliya • ISRAEL

FEI

FEI Number

3006598352

📍

Location

Herzliya

🇮🇱

Country

ISRAEL
🏢

Address

1, Galgalei Ha-Plada, St Industrial Zon, Herzliya, , Israel

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
9/13/2017
Latest Refusal
9/13/2017
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

2901×

DE IMP GMP

The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).

Refusal History

DateProductViolationsDivision
9/13/2017
76DZEIMPLANT, ENDOSSEOUS
290DE IMP GMP
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Hi Tec Implants Ltd's FDA import refusal history?

Hi Tec Implants Ltd (FEI: 3006598352) has 1 FDA import refusal record(s) in our database, spanning from 9/13/2017 to 9/13/2017.

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. Hi Tec Implants Ltd's FEI number is 3006598352.

What types of violations has Hi Tec Implants Ltd received?

Hi Tec Implants Ltd 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 Hi Tec Implants Ltd come from?

All FDA import refusal data for Hi Tec Implants Ltd 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.