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Newlane Limited

⚠️ Moderate Risk

FEI: 3006518638 • Kowloon • HONG KONG

FEI

FEI Number

3006518638

📍

Location

Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

Rm 510 5/F Modern Warehouseno 6 Shing, , Kowloon, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
1/2/2008
Latest Refusal
1/2/2008
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4762×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
1/2/2008
95RFWDVD, DVD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
476NO REGISTR
New England District Office (NWE-DO)
1/2/2008
95RFWDVD, DVD-ROM PLAYER, LASER UTILITY/PERIPHERAL LASER PRODUCTS
476NO REGISTR
New England District Office (NWE-DO)

Frequently Asked Questions

What is Newlane Limited's FDA import refusal history?

Newlane Limited (FEI: 3006518638) has 2 FDA import refusal record(s) in our database, spanning from 1/2/2008 to 1/2/2008.

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. Newlane Limited's FEI number is 3006518638.

What types of violations has Newlane Limited received?

Newlane Limited 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 Newlane Limited come from?

All FDA import refusal data for Newlane Limited 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.