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Natural Source Pty Ltd

⚠️ High Risk

FEI: 3004792946 • Heatherton, Victoria • AUSTRALIA

FEI

FEI Number

3004792946

📍

Location

Heatherton, Victoria

🇦🇺

Country

AUSTRALIA
🏢

Address

42 Corporate Dr, , Heatherton, Victoria, Australia

High Risk

FDA Import Risk Assessment

56.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

19
Total Refusals
3
Unique Violations
4/11/2006
Latest Refusal
4/11/2006
Earliest Refusal

Score Breakdown

Violation Severity
80.5×40%
Refusal Volume
48.2×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7515×

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).

1184×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
223FALSE
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
4/11/2006
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
4/11/2006
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
4/11/2006
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/11/2006
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Natural Source Pty Ltd's FDA import refusal history?

Natural Source Pty Ltd (FEI: 3004792946) has 19 FDA import refusal record(s) in our database, spanning from 4/11/2006 to 4/11/2006.

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. Natural Source Pty Ltd's FEI number is 3004792946.

What types of violations has Natural Source Pty Ltd received?

Natural Source Pty Ltd has been cited for 3 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 Natural Source Pty Ltd come from?

All FDA import refusal data for Natural Source Pty Ltd 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.