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CABB ENTERPRISES

⚠️ Moderate Risk

FEI: 3036049006 • Wangara, Western Australia • AUSTRALIA

FEI

FEI Number

3036049006

📍

Location

Wangara, Western Australia

🇦🇺

Country

AUSTRALIA
🏢

Address

Unit 5 34 Prestige Parade, , Wangara, Western Australia, Australia

Moderate Risk

FDA Import Risk Assessment

48.7
LowModerateHighCritical

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

Statistics

11
Total Refusals
1
Unique Violations
5/29/2025
Latest Refusal
5/29/2025
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
40.0×30%
Recency
73.5×20%
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

34111×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)
5/29/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is CABB ENTERPRISES's FDA import refusal history?

CABB ENTERPRISES (FEI: 3036049006) has 11 FDA import refusal record(s) in our database, spanning from 5/29/2025 to 5/29/2025.

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. CABB ENTERPRISES's FEI number is 3036049006.

What types of violations has CABB ENTERPRISES received?

CABB ENTERPRISES 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 CABB ENTERPRISES come from?

All FDA import refusal data for CABB ENTERPRISES 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.