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Pulteney Investment Ltd

⚠️ Moderate Risk

FEI: 3004144591 • Tsim Sha Tsui, Kowloon • HONG KONG

FEI

FEI Number

3004144591

📍

Location

Tsim Sha Tsui, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

Suite 803, Empire Centre; 68 Mody Road, Tsim Sha Tsui, Kowloon, Hong Kong

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/17/2003
Latest Refusal
10/17/2003
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
10/17/2003
86MVNLENS, CONTACT (DISPOSABLE)
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pulteney Investment Ltd's FDA import refusal history?

Pulteney Investment Ltd (FEI: 3004144591) has 1 FDA import refusal record(s) in our database, spanning from 10/17/2003 to 10/17/2003.

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. Pulteney Investment Ltd's FEI number is 3004144591.

What types of violations has Pulteney Investment Ltd received?

Pulteney Investment 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 Pulteney Investment Ltd come from?

All FDA import refusal data for Pulteney Investment 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.