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Novartis Consumer Health Australasia Pty

✅ Low Risk

FEI: 3003523347 • Auckland • NEW ZEALAND

FEI

FEI Number

3003523347

📍

Location

Auckland

🇳🇿
🏢

Address

Unknown, , Auckland, , New Zealand

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
11/16/2016
Latest Refusal
11/16/2016
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

Refusal History

DateProductViolationsDivision
11/16/2016
54IBT99FIBER, N.E.C.
473LABELING
482NUTRIT LBL
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

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

Novartis Consumer Health Australasia Pty (FEI: 3003523347) has 1 FDA import refusal record(s) in our database, spanning from 11/16/2016 to 11/16/2016.

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. Novartis Consumer Health Australasia Pty's FEI number is 3003523347.

What types of violations has Novartis Consumer Health Australasia Pty received?

Novartis Consumer Health Australasia Pty 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 Australasia Pty come from?

All FDA import refusal data for Novartis Consumer Health Australasia Pty 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.