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HONG KONG ZOEY TRADING CO.,LIMITED

⚠️ Moderate Risk

FEI: 3024192432 • Kwai Chung, New Territories • HONG KONG

FEI

FEI Number

3024192432

📍

Location

Kwai Chung, New Territories

🇭🇰

Country

HONG KONG
🏢

Address

Kwai Fong Estate Nt., Kwai Chung Road, Kwai Chung, New Territories, Hong Kong

Moderate Risk

FDA Import Risk Assessment

29.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/29/2022
Latest Refusal
11/29/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
23.6×20%
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

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).

Refusal History

DateProductViolationsDivision
11/29/2022
73CAFNEBULIZER (DIRECT PATIENT INTERFACE)
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HONG KONG ZOEY TRADING CO.,LIMITED's FDA import refusal history?

HONG KONG ZOEY TRADING CO.,LIMITED (FEI: 3024192432) has 1 FDA import refusal record(s) in our database, spanning from 11/29/2022 to 11/29/2022.

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. HONG KONG ZOEY TRADING CO.,LIMITED's FEI number is 3024192432.

What types of violations has HONG KONG ZOEY TRADING CO.,LIMITED received?

HONG KONG ZOEY TRADING CO.,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 HONG KONG ZOEY TRADING CO.,LIMITED come from?

All FDA import refusal data for HONG KONG ZOEY TRADING CO.,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.