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SHANGHAI YIDIAN INDUSTRY CO., LTD.

✅ Low Risk

FEI: 3010377101 • Shanghai, Shanghai • CHINA

FEI

FEI Number

3010377101

📍

Location

Shanghai, Shanghai

🇨🇳

Country

CHINA
🏢

Address

Plant No.12 Room 201, Fuyong Lu; Song Jiang District, Shanghai, Shanghai, China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
2/25/2015
Latest Refusal
2/25/2015
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
2/25/2015
80KYRBAG, ICE
341REGISTERED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is SHANGHAI YIDIAN INDUSTRY CO., LTD.'s FDA import refusal history?

SHANGHAI YIDIAN INDUSTRY CO., LTD. (FEI: 3010377101) has 1 FDA import refusal record(s) in our database, spanning from 2/25/2015 to 2/25/2015.

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 YIDIAN INDUSTRY CO., LTD.'s FEI number is 3010377101.

What types of violations has SHANGHAI YIDIAN INDUSTRY CO., LTD. received?

SHANGHAI YIDIAN INDUSTRY 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 YIDIAN INDUSTRY CO., LTD. come from?

All FDA import refusal data for SHANGHAI YIDIAN INDUSTRY 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.