ImportRefusal LogoImportRefusal

Tangshan Huamei Healthcare Co Ltd

⚠️ Moderate Risk

FEI: 3008197879 • Tangshan • CHINA

FEI

FEI Number

3008197879

📍

Location

Tangshan

🇨🇳

Country

CHINA
🏢

Address

Nituo, Luannan, , Tangshan, , 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
11/28/2014
Latest Refusal
11/28/2014
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

4771×

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
11/28/2014
80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE,
477HOLES
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Tangshan Huamei Healthcare Co Ltd's FDA import refusal history?

Tangshan Huamei Healthcare Co Ltd (FEI: 3008197879) has 1 FDA import refusal record(s) in our database, spanning from 11/28/2014 to 11/28/2014.

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. Tangshan Huamei Healthcare Co Ltd's FEI number is 3008197879.

What types of violations has Tangshan Huamei Healthcare Co Ltd received?

Tangshan Huamei Healthcare 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 Tangshan Huamei Healthcare Co Ltd come from?

All FDA import refusal data for Tangshan Huamei Healthcare 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.