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SHANGHAI YIZHUI INFORMATION & TECHNOLOGY CO., LTD.

⚠️ High Risk

FEI: 3026510223 • Shanghai • CHINA

FEI

FEI Number

3026510223

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

3rd Floor, No. 1, Lane5001, Xinlong Rd., , Shanghai, , China

High Risk

FDA Import Risk Assessment

51.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
9/24/2024
Latest Refusal
9/24/2024
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
73.7×20%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

Refusal History

DateProductViolationsDivision
9/24/2024
95RFELASER CUTTER, MATERIAL PROCESSING LASER PRODUCTS
126FAILS STD
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHANGHAI YIZHUI INFORMATION & TECHNOLOGY CO., LTD.'s FDA import refusal history?

SHANGHAI YIZHUI INFORMATION & TECHNOLOGY CO., LTD. (FEI: 3026510223) has 1 FDA import refusal record(s) in our database, spanning from 9/24/2024 to 9/24/2024.

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. SHANGHAI YIZHUI INFORMATION & TECHNOLOGY CO., LTD.'s FEI number is 3026510223.

What types of violations has SHANGHAI YIZHUI INFORMATION & TECHNOLOGY CO., LTD. received?

SHANGHAI YIZHUI INFORMATION & TECHNOLOGY 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 SHANGHAI YIZHUI INFORMATION & TECHNOLOGY CO., LTD. come from?

All FDA import refusal data for SHANGHAI YIZHUI INFORMATION & TECHNOLOGY 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.