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Sourcology Ltd

⚠️ Moderate Risk

FEI: 3006461016 • Wan Chai, Hong Kong Island • HONG KONG

FEI

FEI Number

3006461016

📍

Location

Wan Chai, Hong Kong Island

🇭🇰

Country

HONG KONG
🏢

Address

Suite 2303, Convention Avenue, Wan Chai, Hong Kong Island, Hong Kong

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
3/19/2008
Latest Refusal
3/19/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

752×

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
3/19/2008
62FBL47CARBAMIDE PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/19/2008
62FBL47CARBAMIDE PEROXIDE (SOL) (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sourcology Ltd's FDA import refusal history?

Sourcology Ltd (FEI: 3006461016) has 2 FDA import refusal record(s) in our database, spanning from 3/19/2008 to 3/19/2008.

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. Sourcology Ltd's FEI number is 3006461016.

What types of violations has Sourcology Ltd received?

Sourcology Ltd 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 Sourcology Ltd come from?

All FDA import refusal data for Sourcology 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.