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Chun Lung Group Co., Ltd.

⚠️ Moderate Risk

FEI: 3007466253 • Kwai Chung, New Territories • HONG KONG

FEI

FEI Number

3007466253

📍

Location

Kwai Chung, New Territories

🇭🇰

Country

HONG KONG
🏢

Address

Block 1 Lei Muk Shue 2 Estate 44 53 Ta W, , Kwai Chung, New Territories, 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
8/17/2009
Latest Refusal
4/13/2009
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
8/17/2009
66BAS44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Cincinnati District Office (CIN-DO)
4/13/2009
66BAY44NICOTINE DELIVERY SYSTEM
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Chun Lung Group Co., Ltd.'s FDA import refusal history?

Chun Lung Group Co., Ltd. (FEI: 3007466253) has 2 FDA import refusal record(s) in our database, spanning from 4/13/2009 to 8/17/2009.

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. Chun Lung Group Co., Ltd.'s FEI number is 3007466253.

What types of violations has Chun Lung Group Co., Ltd. received?

Chun Lung 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 Chun Lung Group Co., Ltd. come from?

All FDA import refusal data for Chun Lung 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.