ImportRefusal LogoImportRefusal

First Union Group Co Ltd

⚠️ Moderate Risk

FEI: 3007522382 • Kowloon • HONG KONG

FEI

FEI Number

3007522382

📍

Location

Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

610 Nathan Road, , Kowloon, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
6/8/2010
Latest Refusal
6/8/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

752×

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
6/8/2010
66BAY44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
New York District Office (NYK-DO)
6/8/2010
66BAY44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is First Union Group Co Ltd's FDA import refusal history?

First Union Group Co Ltd (FEI: 3007522382) has 2 FDA import refusal record(s) in our database, spanning from 6/8/2010 to 6/8/2010.

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. First Union Group Co Ltd's FEI number is 3007522382.

What types of violations has First Union Group Co Ltd received?

First Union Group Co Ltd 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 First Union Group Co Ltd come from?

All FDA import refusal data for First Union Group Co Ltd 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.