ImportRefusal LogoImportRefusal

Elmore Oil Company Pty Ltd

⚠️ Moderate Risk

FEI: 3007137704 • East Bendigo, Victoria • AUSTRALIA

FEI

FEI Number

3007137704

📍

Location

East Bendigo, Victoria

🇦🇺

Country

AUSTRALIA
🏢

Address

U 1 70 Powells Ave, , East Bendigo, Victoria, 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
2/22/2013
Latest Refusal
2/22/2013
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
2/22/2013
66YY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Elmore Oil Company Pty Ltd's FDA import refusal history?

Elmore Oil Company Pty Ltd (FEI: 3007137704) has 1 FDA import refusal record(s) in our database, spanning from 2/22/2013 to 2/22/2013.

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. Elmore Oil Company Pty Ltd's FEI number is 3007137704.

What types of violations has Elmore Oil Company Pty Ltd received?

Elmore Oil Company 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 Elmore Oil Company Pty Ltd come from?

All FDA import refusal data for Elmore Oil Company 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.