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SHANGHAI YIGE IMPORT AND EXPORT

⚠️ Moderate Risk

FEI: 3030954591 • Shanghai • CHINA

FEI

FEI Number

3030954591

📍

Location

Shanghai

🇨🇳

Country

CHINA
🏢

Address

No 158 Linsheng Rd No 1, , Shanghai, , China

Moderate Risk

FDA Import Risk Assessment

34.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
1/9/2026
Latest Refusal
1/9/2026
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
91.1×20%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
1/9/2026
76KIFRESIN, ROOT CANAL FILLING
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHANGHAI YIGE IMPORT AND EXPORT's FDA import refusal history?

SHANGHAI YIGE IMPORT AND EXPORT (FEI: 3030954591) has 1 FDA import refusal record(s) in our database, spanning from 1/9/2026 to 1/9/2026.

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 YIGE IMPORT AND EXPORT's FEI number is 3030954591.

What types of violations has SHANGHAI YIGE IMPORT AND EXPORT received?

SHANGHAI YIGE IMPORT AND EXPORT 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 YIGE IMPORT AND EXPORT come from?

All FDA import refusal data for SHANGHAI YIGE IMPORT AND EXPORT 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.