ImportRefusal LogoImportRefusal

Luen Hop Pharmacetical.co

⚠️ Moderate Risk

FEI: 3004336514 • Wong Chuk Hang, Hong Kong Island • HONG KONG

FEI

FEI Number

3004336514

📍

Location

Wong Chuk Hang, Hong Kong Island

🇭🇰

Country

HONG KONG
🏢

Address

Room D, 15th Floor, Kwai Bo Industrial Building; 40 Wong Chuk Hang Road, Wong Chuk Hang, Hong Kong Island, Hong Kong

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/19/2023
Latest Refusal
9/19/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
53.3×20%
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
9/19/2023
54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
118NOT LISTED
3280FRNMFGREG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Luen Hop Pharmacetical.co's FDA import refusal history?

Luen Hop Pharmacetical.co (FEI: 3004336514) has 1 FDA import refusal record(s) in our database, spanning from 9/19/2023 to 9/19/2023.

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. Luen Hop Pharmacetical.co's FEI number is 3004336514.

What types of violations has Luen Hop Pharmacetical.co received?

Luen Hop Pharmacetical.co 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 Luen Hop Pharmacetical.co come from?

All FDA import refusal data for Luen Hop Pharmacetical.co 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.