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High Goal Intertrans Shejiang Corp

⚠️ Moderate Risk

FEI: 3005096739 • Hangzhou • CHINA

FEI

FEI Number

3005096739

📍

Location

Hangzhou

🇨🇳

Country

CHINA
🏢

Address

Zaixingxiang Desheng Rd, , Hangzhou, , China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/18/2005
Latest Refusal
5/18/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

161×

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
5/18/2005
61JIY11GEMFIBROZIL (ANTI-CHOLESTEREMIC)
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is High Goal Intertrans Shejiang Corp's FDA import refusal history?

High Goal Intertrans Shejiang Corp (FEI: 3005096739) has 1 FDA import refusal record(s) in our database, spanning from 5/18/2005 to 5/18/2005.

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. High Goal Intertrans Shejiang Corp's FEI number is 3005096739.

What types of violations has High Goal Intertrans Shejiang Corp received?

High Goal Intertrans Shejiang Corp 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 High Goal Intertrans Shejiang Corp come from?

All FDA import refusal data for High Goal Intertrans Shejiang Corp 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.