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Novartis Consumer Health

✅ Low Risk

FEI: 3004423432 • Brussels, Brussels • BELGIUM

FEI

FEI Number

3004423432

📍

Location

Brussels, Brussels

🇧🇪

Country

BELGIUM
🏢

Address

Rue De Wand 211-213, , Brussels, Brussels, Belgium

Low Risk

FDA Import Risk Assessment

18.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
3/4/2005
Latest Refusal
3/4/2005
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
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

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
3/4/2005
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
335LACKS N/C
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

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

Novartis Consumer Health (FEI: 3004423432) has 1 FDA import refusal record(s) in our database, spanning from 3/4/2005 to 3/4/2005.

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's FEI number is 3004423432.

What types of violations has Novartis Consumer Health received?

Novartis Consumer Health 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 Novartis Consumer Health come from?

All FDA import refusal data for Novartis Consumer Health 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.