ImportRefusal LogoImportRefusal

Jiangsu Guo Tai International Group Co. Ltd

✅ Low Risk

FEI: 3002545789 • Zhangjiagang • CHINA

FEI

FEI Number

3002545789

📍

Location

Zhangjiagang

🇨🇳

Country

CHINA
🏢

Address

11/F Guotai Buildingremin Road Oo, , Zhangjiagang, , China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/16/2008
Latest Refusal
1/16/2008
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
1/16/2008
62FOO18ICHTHAMMOL (ANTI-INFECTIVE, TOPICAL)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Jiangsu Guo Tai International Group Co. Ltd's FDA import refusal history?

Jiangsu Guo Tai International Group Co. Ltd (FEI: 3002545789) has 1 FDA import refusal record(s) in our database, spanning from 1/16/2008 to 1/16/2008.

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 Guo Tai International Group Co. Ltd's FEI number is 3002545789.

What types of violations has Jiangsu Guo Tai International Group Co. Ltd received?

Jiangsu Guo Tai International 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 Jiangsu Guo Tai International Group Co. Ltd come from?

All FDA import refusal data for Jiangsu Guo Tai International 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.