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Organic Care Australia Pty. Ltd.

⚠️ Moderate Risk

FEI: 3008055081 • Bundoora • AUSTRALIA

FEI

FEI Number

3008055081

📍

Location

Bundoora

🇦🇺

Country

AUSTRALIA
🏢

Address

13/226 Plenty Road, , Bundoora, , Australia

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/21/2010
Latest Refusal
6/21/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

751×

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
6/21/2010
65GDY99PIGMENTATION AGENT N.E.C.
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Organic Care Australia Pty. Ltd.'s FDA import refusal history?

Organic Care Australia Pty. Ltd. (FEI: 3008055081) has 1 FDA import refusal record(s) in our database, spanning from 6/21/2010 to 6/21/2010.

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. Organic Care Australia Pty. Ltd.'s FEI number is 3008055081.

What types of violations has Organic Care Australia Pty. Ltd. received?

Organic Care Australia Pty. Ltd. 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 Organic Care Australia Pty. Ltd. come from?

All FDA import refusal data for Organic Care Australia 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.