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King Fortress (Hong Kong) Limited

⚠️ High Risk

FEI: 3006023334 • Sha Tin, New Territories • HONG KONG

FEI

FEI Number

3006023334

📍

Location

Sha Tin, New Territories

🇭🇰

Country

HONG KONG
🏢

Address

Wah Sang, 14-18 Wong Chuk Yeung Street, Sha Tin, New Territories, Hong Kong

High Risk

FDA Import Risk Assessment

61.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

10
Total Refusals
4
Unique Violations
7/15/2022
Latest Refusal
7/15/2022
Earliest Refusal

Score Breakdown

Violation Severity
84.5×40%
Refusal Volume
38.6×30%
Recency
30.1×20%
Frequency
100.0×10%
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

7510×

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).

3307×

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

1782×

COL ADDED

The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

Refusal History

DateProductViolationsDivision
7/15/2022
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
330UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/15/2022
53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
330UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/15/2022
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
330UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/15/2022
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
330UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/15/2022
53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
330UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/15/2022
53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
330UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/15/2022
53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)
330UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/15/2022
53KA05SHAVING CREAM (AEROSOL, BRUSHLESS, LATHER) (SHAVING PREPARATIONS)
178COL ADDED
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/15/2022
53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
178COL ADDED
75UNAPPROVED
Division of Southeast Imports (DSEI)
7/15/2022
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
11UNSAFE COL
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is King Fortress (Hong Kong) Limited's FDA import refusal history?

King Fortress (Hong Kong) Limited (FEI: 3006023334) has 10 FDA import refusal record(s) in our database, spanning from 7/15/2022 to 7/15/2022.

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. King Fortress (Hong Kong) Limited's FEI number is 3006023334.

What types of violations has King Fortress (Hong Kong) Limited received?

King Fortress (Hong Kong) Limited 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 King Fortress (Hong Kong) Limited come from?

All FDA import refusal data for King Fortress (Hong Kong) 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.