ImportRefusal LogoImportRefusal

CHINA SURGICAL DRESSINGS CENTERCO., LTD.

⚠️ Moderate Risk

FEI: 3013840021 • Changhwa City • TAIWAN

FEI

FEI Number

3013840021

📍

Location

Changhwa City

🇹🇼

Country

TAIWAN
🏢

Address

No. 21, Changnan Road,Sec. 6, 424 Lane, , Changhwa City, , Taiwan

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/2/2020
Latest Refusal
8/20/2020
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

783×

STERILITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
9/2/2020
80FQMBANDAGE, ELASTIC
78STERILITY
Division of Southeast Imports (DSEI)
8/20/2020
80FQMBANDAGE, ELASTIC
78STERILITY
Division of Southeast Imports (DSEI)
8/20/2020
80FQMBANDAGE, ELASTIC
78STERILITY
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is CHINA SURGICAL DRESSINGS CENTERCO., LTD.'s FDA import refusal history?

CHINA SURGICAL DRESSINGS CENTERCO., LTD. (FEI: 3013840021) has 3 FDA import refusal record(s) in our database, spanning from 8/20/2020 to 9/2/2020.

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. CHINA SURGICAL DRESSINGS CENTERCO., LTD.'s FEI number is 3013840021.

What types of violations has CHINA SURGICAL DRESSINGS CENTERCO., LTD. received?

CHINA SURGICAL DRESSINGS CENTERCO., 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 CHINA SURGICAL DRESSINGS CENTERCO., LTD. come from?

All FDA import refusal data for CHINA SURGICAL DRESSINGS CENTERCO., 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.