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WAH YAN HONG CHEMICAL FACTORY

⚠️ Moderate Risk

FEI: 3004274057 • HONG KONG, HK-NA • HONG KONG

FEI

FEI Number

3004274057

📍

Location

HONG KONG, HK-NA

🇭🇰

Country

HONG KONG
🏢

Address

G/f., 37 Tao Yuen Street, Tai Hung Tung, HONG KONG, HK-NA, Hong Kong

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/31/2013
Latest Refusal
7/31/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

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
7/31/2013
66V99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is WAH YAN HONG CHEMICAL FACTORY's FDA import refusal history?

WAH YAN HONG CHEMICAL FACTORY (FEI: 3004274057) has 1 FDA import refusal record(s) in our database, spanning from 7/31/2013 to 7/31/2013.

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. WAH YAN HONG CHEMICAL FACTORY's FEI number is 3004274057.

What types of violations has WAH YAN HONG CHEMICAL FACTORY received?

WAH YAN HONG CHEMICAL FACTORY has been cited for 1 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 WAH YAN HONG CHEMICAL FACTORY come from?

All FDA import refusal data for WAH YAN HONG CHEMICAL FACTORY 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.