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Dexon Ltd.

⚠️ Moderate Risk

FEI: 1000366745 • Hadera • ISRAEL

FEI

FEI Number

1000366745

📍

Location

Hadera

🇮🇱

Country

ISRAEL
🏢

Address

P. O. Box 50, , Hadera, , Israel

Moderate Risk

FDA Import Risk Assessment

43.2
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
12/10/2009
Latest Refusal
5/3/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
5.3×10%
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

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
12/10/2009
62VCY46ZANAMIVIR (ANTI-VIRAL)
75UNAPPROVED
Cincinnati District Office (CIN-DO)
5/3/2004
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)
5/3/2004
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Dexon Ltd.'s FDA import refusal history?

Dexon Ltd. (FEI: 1000366745) has 3 FDA import refusal record(s) in our database, spanning from 5/3/2004 to 12/10/2009.

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. Dexon Ltd.'s FEI number is 1000366745.

What types of violations has Dexon Ltd. received?

Dexon 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 Dexon Ltd. come from?

All FDA import refusal data for Dexon 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.