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KONG HING HONG

⚠️ Moderate Risk

FEI: 3011146278 • Kennedy Town, Hong Kong Island • HONG KONG

FEI

FEI Number

3011146278

📍

Location

Kennedy Town, Hong Kong Island

🇭🇰

Country

HONG KONG
🏢

Address

Kwong Ga Factory Building, 64 Victoria Road, Kennedy Town, Hong Kong Island, Hong Kong

Moderate Risk

FDA Import Risk Assessment

37.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
4
Unique Violations
8/24/2004
Latest Refusal
5/10/2004
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

1171×

DANGEROUS

The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.

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).

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

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
8/24/2004
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
117DANGEROUS
223FALSE
Los Angeles District Office (LOS-DO)
5/10/2004
61XAL39PHENIRAMINE MALEATE (ANTI-HISTAMINIC)
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is KONG HING HONG's FDA import refusal history?

KONG HING HONG (FEI: 3011146278) has 2 FDA import refusal record(s) in our database, spanning from 5/10/2004 to 8/24/2004.

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. KONG HING HONG's FEI number is 3011146278.

What types of violations has KONG HING HONG received?

KONG HING HONG has been cited for 4 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 KONG HING HONG come from?

All FDA import refusal data for KONG HING HONG 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.