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DRAGON WELL TRANSPORTATION LTD

⚠️ Moderate Risk

FEI: 3014524272 • Kwai Fong • HONG KONG

FEI

FEI Number

3014524272

📍

Location

Kwai Fong

🇭🇰

Country

HONG KONG
🏢

Address

Unit A G/F Blk 2 Kwai T, , Kwai Fong, , 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
2
Unique Violations
4/5/2023
Latest Refusal
4/5/2023
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
44.0×20%
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

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
4/5/2023
90IYNSYSTEM, IMAGING, PULSED DOPPLER, ULTRASONIC
118NOT LISTED
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is DRAGON WELL TRANSPORTATION LTD's FDA import refusal history?

DRAGON WELL TRANSPORTATION LTD (FEI: 3014524272) has 1 FDA import refusal record(s) in our database, spanning from 4/5/2023 to 4/5/2023.

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. DRAGON WELL TRANSPORTATION LTD's FEI number is 3014524272.

What types of violations has DRAGON WELL TRANSPORTATION LTD received?

DRAGON WELL TRANSPORTATION LTD has been cited for 2 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 DRAGON WELL TRANSPORTATION LTD come from?

All FDA import refusal data for DRAGON WELL TRANSPORTATION 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.