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Changzhou Hualian Health Dressing Co., Ltd.

✅ Low Risk

FEI: 3003807757 • Changzhou, Jiangsu • CHINA

FEI

FEI Number

3003807757

📍

Location

Changzhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

NO. 55 Yuejin Lu, Wujin, Changzhou, Jiangsu, China

Low Risk

FDA Import Risk Assessment

20.8
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
2
Unique Violations
3/25/2011
Latest Refusal
10/24/2008
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
8.3×10%
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

3412×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

4841×

DV NAME

The article appears to be a device and its labeling fails to bear the proprietary or established name.

Refusal History

DateProductViolationsDivision
3/25/2011
80KGXTAPE AND BANDAGE, ADHESIVE
341REGISTERED
484DV NAME
New York District Office (NYK-DO)
10/24/2008
80KGXTAPE AND BANDAGE, ADHESIVE
341REGISTERED
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Changzhou Hualian Health Dressing Co., Ltd.'s FDA import refusal history?

Changzhou Hualian Health Dressing Co., Ltd. (FEI: 3003807757) has 2 FDA import refusal record(s) in our database, spanning from 10/24/2008 to 3/25/2011.

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. Changzhou Hualian Health Dressing Co., Ltd.'s FEI number is 3003807757.

What types of violations has Changzhou Hualian Health Dressing Co., Ltd. received?

Changzhou Hualian Health Dressing Co., Ltd. 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 Changzhou Hualian Health Dressing Co., Ltd. come from?

All FDA import refusal data for Changzhou Hualian Health Dressing 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.