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Novartis Consumer Health Spa

⚠️ Moderate Risk

FEI: 3004622138 • Driggio • ITALY

FEI

FEI Number

3004622138

📍

Location

Driggio

🇮🇹

Country

ITALY
🏢

Address

Strada Statale 23 Km 20,5, , Driggio, , Italy

Moderate Risk

FDA Import Risk Assessment

42.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
11/9/2018
Latest Refusal
11/1/2004
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
2.1×10%
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
11/9/2018
60WDF08CARBANTEL LAURYL SULFATE (ANTHELMINTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/8/2006
62GDC90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY)
75UNAPPROVED
Florida District Office (FLA-DO)
11/1/2004
61PDA60NATEGLINIDE (ANTI-DIABETIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Novartis Consumer Health Spa's FDA import refusal history?

Novartis Consumer Health Spa (FEI: 3004622138) has 3 FDA import refusal record(s) in our database, spanning from 11/1/2004 to 11/9/2018.

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. Novartis Consumer Health Spa's FEI number is 3004622138.

What types of violations has Novartis Consumer Health Spa received?

Novartis Consumer Health Spa 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 Novartis Consumer Health Spa come from?

All FDA import refusal data for Novartis Consumer Health Spa 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.