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TG Medical (China) Incorporation

⚠️ Moderate Risk

FEI: 3005478299 • Suzhoush, Jiangsu • CHINA

FEI

FEI Number

3005478299

📍

Location

Suzhoush, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

3 Xitang Road, Xizhang Town, Suzhoush, Jiangsu, China

Moderate Risk

FDA Import Risk Assessment

41.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
7/8/2009
Latest Refusal
6/8/2009
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

4775×

HOLES

The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.

Refusal History

DateProductViolationsDivision
7/8/2009
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Division of Southeast Imports (DSEI)
6/8/2009
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
New Orleans District Office (NOL-DO)
6/8/2009
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
New Orleans District Office (NOL-DO)
6/8/2009
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
New Orleans District Office (NOL-DO)
6/8/2009
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is TG Medical (China) Incorporation's FDA import refusal history?

TG Medical (China) Incorporation (FEI: 3005478299) has 5 FDA import refusal record(s) in our database, spanning from 6/8/2009 to 7/8/2009.

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. TG Medical (China) Incorporation's FEI number is 3005478299.

What types of violations has TG Medical (China) Incorporation received?

TG Medical (China) Incorporation 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 TG Medical (China) Incorporation come from?

All FDA import refusal data for TG Medical (China) Incorporation 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.