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DALITONG TRADING LIMITED

⚠️ Moderate Risk

FEI: 3021514831 • Yau Ma Tei, Kowloon • HONG KONG

FEI

FEI Number

3021514831

📍

Location

Yau Ma Tei, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

16/F, Kowloon Building; 555 Nathan Road, Yau Ma Tei, Kowloon, Hong Kong

Moderate Risk

FDA Import Risk Assessment

25.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/18/2022
Latest Refusal
2/18/2022
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
8.0×20%
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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
2/18/2022
79OHOFIRST AID KIT WITHOUT DRUG
118NOT LISTED
3280FRNMFGREG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is DALITONG TRADING LIMITED's FDA import refusal history?

DALITONG TRADING LIMITED (FEI: 3021514831) has 1 FDA import refusal record(s) in our database, spanning from 2/18/2022 to 2/18/2022.

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. DALITONG TRADING LIMITED's FEI number is 3021514831.

What types of violations has DALITONG TRADING LIMITED received?

DALITONG TRADING LIMITED 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 DALITONG TRADING LIMITED come from?

All FDA import refusal data for DALITONG TRADING 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.