ImportRefusal LogoImportRefusal

Jiangsu Soho International Group Wuxi Co., Ltd.

✅ Low Risk

FEI: 3007725107 • Jingsu • CHINA

FEI

FEI Number

3007725107

📍

Location

Jingsu

🇨🇳

Country

CHINA
🏢

Address

37 Beicangmen, , Jingsu, , China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/31/2009
Latest Refusal
8/31/2009
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3411×

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).

Refusal History

DateProductViolationsDivision
8/31/2009
80LGXTABLE, EXAMINATION, MEDICAL, POWERED
341REGISTERED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Jiangsu Soho International Group Wuxi Co., Ltd.'s FDA import refusal history?

Jiangsu Soho International Group Wuxi Co., Ltd. (FEI: 3007725107) has 1 FDA import refusal record(s) in our database, spanning from 8/31/2009 to 8/31/2009.

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. Jiangsu Soho International Group Wuxi Co., Ltd.'s FEI number is 3007725107.

What types of violations has Jiangsu Soho International Group Wuxi Co., Ltd. received?

Jiangsu Soho International Group Wuxi 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 Jiangsu Soho International Group Wuxi Co., Ltd. come from?

All FDA import refusal data for Jiangsu Soho International Group Wuxi 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.