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BIOSOTA ORGANICS PTY LTD

✅ Low Risk

FEI: 3013713654 • Sydney • AUSTRALIA

FEI

FEI Number

3013713654

📍

Location

Sydney

🇦🇺

Country

AUSTRALIA
🏢

Address

Unit 27/4-6 Hamlay Rd M, , Sydney, , Australia

Low Risk

FDA Import Risk Assessment

23.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/29/2017
Latest Refusal
12/29/2017
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
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

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

4881×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
12/29/2017
36CGT04HONEY
473LABELING
482NUTRIT LBL
488HEALTH C
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is BIOSOTA ORGANICS PTY LTD's FDA import refusal history?

BIOSOTA ORGANICS PTY LTD (FEI: 3013713654) has 1 FDA import refusal record(s) in our database, spanning from 12/29/2017 to 12/29/2017.

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. BIOSOTA ORGANICS PTY LTD's FEI number is 3013713654.

What types of violations has BIOSOTA ORGANICS PTY LTD received?

BIOSOTA ORGANICS PTY LTD has been cited for 3 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 BIOSOTA ORGANICS PTY LTD come from?

All FDA import refusal data for BIOSOTA ORGANICS 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.