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Nacooma Enterprises Pty Ltd

⚠️ Moderate Risk

FEI: 3005513015 • Romsey, Victoria • AUSTRALIA

FEI

FEI Number

3005513015

📍

Location

Romsey, Victoria

🇦🇺

Country

AUSTRALIA
🏢

Address

Po Box 277, , Romsey, Victoria, Australia

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/9/2009
Latest Refusal
2/9/2009
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

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.

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
2/9/2009
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
321LACKS N/C
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Nacooma Enterprises Pty Ltd's FDA import refusal history?

Nacooma Enterprises Pty Ltd (FEI: 3005513015) has 1 FDA import refusal record(s) in our database, spanning from 2/9/2009 to 2/9/2009.

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. Nacooma Enterprises Pty Ltd's FEI number is 3005513015.

What types of violations has Nacooma Enterprises Pty Ltd received?

Nacooma Enterprises Pty Ltd 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 Nacooma Enterprises Pty Ltd come from?

All FDA import refusal data for Nacooma Enterprises 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.