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M VANDERHELM N VANDERHELM

⚠️ Moderate Risk

FEI: 3029901751 • Southport, Queensland • AUSTRALIA

FEI

FEI Number

3029901751

📍

Location

Southport, Queensland

🇦🇺

Country

AUSTRALIA
🏢

Address

U B 28 Shirley St, So, Southport, Queensland, Australia

Moderate Risk

FDA Import Risk Assessment

41.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/14/2023
Latest Refusal
12/14/2023
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
11.2×30%
Recency
58.0×20%
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

21601×

LACK NOTIF

Adulterated, 801(a)(3), lack of documentation establishing that the infant formula meets all notification conditions required by 412(c) or 412(d), Prohibited Act, Section 301(s).

2601×

FALSE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

Refusal History

DateProductViolationsDivision
12/14/2023
40PVT99OTHER FORMULA PRODUCTS, N.E.C., POWDER FORMULA
2160LACK NOTIF
260FALSE
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is M VANDERHELM N VANDERHELM's FDA import refusal history?

M VANDERHELM N VANDERHELM (FEI: 3029901751) has 1 FDA import refusal record(s) in our database, spanning from 12/14/2023 to 12/14/2023.

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. M VANDERHELM N VANDERHELM's FEI number is 3029901751.

What types of violations has M VANDERHELM N VANDERHELM received?

M VANDERHELM N VANDERHELM 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 M VANDERHELM N VANDERHELM come from?

All FDA import refusal data for M VANDERHELM N VANDERHELM 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.