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SHUN DA (XINGHUA) CO., LTD.

⚠️ Moderate Risk

FEI: 3007695695 • Taizhou, Jiangsu • CHINA

FEI

FEI Number

3007695695

📍

Location

Taizhou, Jiangsu

🇨🇳

Country

CHINA
🏢

Address

Lot 20, Tian Shui Hua Ting Yuan; Xinghua, Taizhou, Jiangsu, 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
4/21/2011
Latest Refusal
4/21/2011
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
4/21/2011
80LYYGLOVE, PATIENT EXAMINATION, LATEX
477HOLES
New York District Office (NYK-DO)

Frequently Asked Questions

What is SHUN DA (XINGHUA) CO., LTD.'s FDA import refusal history?

SHUN DA (XINGHUA) CO., LTD. (FEI: 3007695695) has 1 FDA import refusal record(s) in our database, spanning from 4/21/2011 to 4/21/2011.

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. SHUN DA (XINGHUA) CO., LTD.'s FEI number is 3007695695.

What types of violations has SHUN DA (XINGHUA) CO., LTD. received?

SHUN DA (XINGHUA) 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 SHUN DA (XINGHUA) CO., LTD. come from?

All FDA import refusal data for SHUN DA (XINGHUA) 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.