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MEDICAL QUANT LTD.

⚠️ Moderate Risk

FEI: 3007335145 • Kfar Saba • ISRAEL

FEI

FEI Number

3007335145

📍

Location

Kfar Saba

🇮🇱

Country

ISRAEL
🏢

Address

14, Hattash St, , Kfar Saba, , Israel

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
10/19/2009
Latest Refusal
10/19/2009
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

472×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
10/19/2009
84LLPLASER FOR PAIN THERAPY
118NOT LISTED
47NON STD
New Orleans District Office (NOL-DO)
10/19/2009
79GEXPOWERED LASER SURGICAL INSTRUMENTS
118NOT LISTED
47NON STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is MEDICAL QUANT LTD.'s FDA import refusal history?

MEDICAL QUANT LTD. (FEI: 3007335145) has 2 FDA import refusal record(s) in our database, spanning from 10/19/2009 to 10/19/2009.

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. MEDICAL QUANT LTD.'s FEI number is 3007335145.

What types of violations has MEDICAL QUANT LTD. received?

MEDICAL QUANT LTD. has been cited for 2 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 MEDICAL QUANT LTD. come from?

All FDA import refusal data for MEDICAL QUANT 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.