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Austrailian Independent Wholesalers

✅ Low Risk

FEI: 3002521228 • Hume, Australian Capital Territory • AUSTRALIA

FEI

FEI Number

3002521228

📍

Location

Hume, Australian Capital Territory

🇦🇺

Country

AUSTRALIA
🏢

Address

34 - 42 Sheppard St, , Hume, Australian Capital Territory, Australia

Low Risk

FDA Import Risk Assessment

23.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
5
Unique Violations
7/11/2003
Latest Refusal
6/4/2002
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
18.2×10%
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

1181×

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).

2741×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

2761×

PRESRV LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.

3211×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

DateProductViolationsDivision
7/11/2003
65FBK99WATER N.E.C. (PHARMACEUTIC AID)
118NOT LISTED
335LACKS N/C
Atlanta District Office (ATL-DO)
6/4/2002
34FFY02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT
274COLOR LBLG
276PRESRV LBL
321LACKS N/C
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Austrailian Independent Wholesalers's FDA import refusal history?

Austrailian Independent Wholesalers (FEI: 3002521228) has 2 FDA import refusal record(s) in our database, spanning from 6/4/2002 to 7/11/2003.

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. Austrailian Independent Wholesalers's FEI number is 3002521228.

What types of violations has Austrailian Independent Wholesalers received?

Austrailian Independent Wholesalers has been cited for 5 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 Austrailian Independent Wholesalers come from?

All FDA import refusal data for Austrailian Independent Wholesalers 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.