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Profit International Enterprises Ltd

⚠️ Moderate Risk

FEI: 3005167670 • Tsim Sha Tsui, Kowloon • HONG KONG

FEI

FEI Number

3005167670

📍

Location

Tsim Sha Tsui, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

/ Room 702 / Tung Ying, 100 Nathan Road, Tsim Sha Tsui, Kowloon, Hong Kong

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
10/14/2005
Latest Refusal
10/14/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

1712×

CONTAINER

The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.

1181×

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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
10/14/2005
52AJA31BOWLS, ANY SIZE (FOODWARE, COOKWARE & TABLEWARE)
171CONTAINER
Florida District Office (FLA-DO)
10/14/2005
52AI26CUPS, MUGS (FOODWARE, COOKWARE & TABLEWARE)
171CONTAINER
Florida District Office (FLA-DO)
10/14/2005
80FQMBANDAGE, ELASTIC
118NOT LISTED
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Profit International Enterprises Ltd's FDA import refusal history?

Profit International Enterprises Ltd (FEI: 3005167670) has 3 FDA import refusal record(s) in our database, spanning from 10/14/2005 to 10/14/2005.

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. Profit International Enterprises Ltd's FEI number is 3005167670.

What types of violations has Profit International Enterprises Ltd received?

Profit International Enterprises 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 Profit International Enterprises Ltd come from?

All FDA import refusal data for Profit International Enterprises 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.