ImportRefusal LogoImportRefusal

Sunmax Enterprise Shanghai Co. Ltd.

⚠️ Moderate Risk

FEI: 1000653202 • Shanghai, Jinshan • CHINA

FEI

FEI Number

1000653202

📍

Location

Shanghai, Jinshan

🇨🇳

Country

CHINA
🏢

Address

# 2, Zhu Hang New; Industry Zone, Shanghai, Jinshan, 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
9/10/2003
Latest Refusal
9/10/2003
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
9/10/2003
80LYZGLOVE, PATIENT EXAMINATION, VINYL
477HOLES
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Sunmax Enterprise Shanghai Co. Ltd.'s FDA import refusal history?

Sunmax Enterprise Shanghai Co. Ltd. (FEI: 1000653202) has 1 FDA import refusal record(s) in our database, spanning from 9/10/2003 to 9/10/2003.

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. Sunmax Enterprise Shanghai Co. Ltd.'s FEI number is 1000653202.

What types of violations has Sunmax Enterprise Shanghai Co. Ltd. received?

Sunmax Enterprise Shanghai 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 Sunmax Enterprise Shanghai Co. Ltd. come from?

All FDA import refusal data for Sunmax Enterprise Shanghai 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.