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Zhangjiagang City Xinhui Import and Export Trading Co., Ltd.

⚠️ Moderate Risk

FEI: 3006630288 • Zhangjiagang City • CHINA

FEI

FEI Number

3006630288

📍

Location

Zhangjiagang City

🇨🇳

Country

CHINA
🏢

Address

Yuefeng Mansion,, Zhangjiagang Economic Development Zone, Zhangjiagang City, , China

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/9/2011
Latest Refusal
12/1/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
12/9/2011
61HAS45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III)
16DIRECTIONS
New York District Office (NYK-DO)
12/1/2011
61HAS45SODIUM SULFACETAMIDE (ANTI-BACTERIAL, PART III)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Zhangjiagang City Xinhui Import and Export Trading Co., Ltd.'s FDA import refusal history?

Zhangjiagang City Xinhui Import and Export Trading Co., Ltd. (FEI: 3006630288) has 2 FDA import refusal record(s) in our database, spanning from 12/1/2011 to 12/9/2011.

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. Zhangjiagang City Xinhui Import and Export Trading Co., Ltd.'s FEI number is 3006630288.

What types of violations has Zhangjiagang City Xinhui Import and Export Trading Co., Ltd. received?

Zhangjiagang City Xinhui Import and Export Trading 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 Zhangjiagang City Xinhui Import and Export Trading Co., Ltd. come from?

All FDA import refusal data for Zhangjiagang City Xinhui Import and Export Trading 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.