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Babies Only

⚠️ Moderate Risk

FEI: 3006978831 • Davesford • AUSTRALIA

FEI

FEI Number

3006978831

📍

Location

Davesford

🇦🇺

Country

AUSTRALIA
🏢

Address

45a Vincent Street, , Davesford, , Australia

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/2/2009
Latest Refusal
2/2/2009
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

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).

Refusal History

DateProductViolationsDivision
2/2/2009
53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/2/2009
53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
118NOT LISTED
Los Angeles District Office (LOS-DO)
2/2/2009
53LC09SKIN FRESHENERS (SKIN CARE PREPARATIONS)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Babies Only's FDA import refusal history?

Babies Only (FEI: 3006978831) has 3 FDA import refusal record(s) in our database, spanning from 2/2/2009 to 2/2/2009.

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. Babies Only's FEI number is 3006978831.

What types of violations has Babies Only received?

Babies Only 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 Babies Only come from?

All FDA import refusal data for Babies Only 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.