Luen Hop Trading Company

⚠️ Moderate Risk

FEI: 3003712511 • Hong Kong • HONG KONG

FEI

FEI Number

3003712511

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG

🏢

Address

Rm C3 3th Fl. Kwai Bo Ind. Building40, , Hong Kong, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

42.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

10/6/2003

Latest Refusal

10/6/2003

Earliest Refusal

Score Breakdown

Violation Severity

72.0×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

Violation Summary

755×

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).

1184×

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

Date	Product	Violations	Division
10/6/2003	66VBF99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
10/6/2003	66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
10/6/2003	66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
10/6/2003	66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
10/6/2003	66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Luen Hop Trading Company's FDA import refusal history?

Luen Hop Trading Company (FEI: 3003712511) has 5 FDA import refusal record(s) in our database, spanning from 10/6/2003 to 10/6/2003.

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. Luen Hop Trading Company's FEI number is 3003712511.

What types of violations has Luen Hop Trading Company received?

Luen Hop Trading Company 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 Luen Hop Trading Company come from?

All FDA import refusal data for Luen Hop Trading Company 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.