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Winner Medical International Trading Co. Ltd.

⚠️ Moderate Risk

FEI: 3004178531 • King's Park, Kowloon • HONG KONG

FEI

FEI Number

3004178531

📍

Location

King's Park, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

193 King's Park Hill Road, , King's Park, Kowloon, Hong Kong

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
7/27/2004
Latest Refusal
7/27/2004
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
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

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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

751×

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
7/27/2004
80LKBPAD, ALCOHOL, DEVICE DISINFECTANT
341REGISTERED
508NO 510(K)
Division of Southeast Imports (DSEI)
7/27/2004
62FAK20IODINE (ANTI-INFECTIVE, TOPICAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Winner Medical International Trading Co. Ltd.'s FDA import refusal history?

Winner Medical International Trading Co. Ltd. (FEI: 3004178531) has 2 FDA import refusal record(s) in our database, spanning from 7/27/2004 to 7/27/2004.

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. Winner Medical International Trading Co. Ltd.'s FEI number is 3004178531.

What types of violations has Winner Medical International Trading Co. Ltd. received?

Winner Medical International Trading Co. 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 Winner Medical International Trading Co. Ltd. come from?

All FDA import refusal data for Winner Medical International Trading Co. 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.