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SANDOZ-HEXAL

⚠️ Moderate Risk

FEI: 3012935343 • Origgio, Varese • ITALY

FEI

FEI Number

3012935343

📍

Location

Origgio, Varese

🇮🇹

Country

ITALY
🏢

Address

Largo Umberto Boccioni, , Origgio, Varese, Italy

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/21/2016
Latest Refusal
12/21/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
12/21/2016
61WDA45FLUCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC)
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SANDOZ-HEXAL's FDA import refusal history?

SANDOZ-HEXAL (FEI: 3012935343) has 1 FDA import refusal record(s) in our database, spanning from 12/21/2016 to 12/21/2016.

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. SANDOZ-HEXAL's FEI number is 3012935343.

What types of violations has SANDOZ-HEXAL received?

SANDOZ-HEXAL 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 SANDOZ-HEXAL come from?

All FDA import refusal data for SANDOZ-HEXAL 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.