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Shanghai Trend International Trade Co Ltd

✅ Low Risk

FEI: 3006979420 • Zhenjian • CHINA

FEI

FEI Number

3006979420

📍

Location

Zhenjian

🇨🇳

Country

CHINA
🏢

Address

Yanhu Area Wenzhou, , Zhenjian, , China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/31/2008
Latest Refusal
10/31/2008
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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
10/31/2008
89NXUSTIMULATOR, ULTRASOUND AND MUSCLE, FOR USE IN APPLING THERAPEUTIC DEEP HEAT, OVER THE COUNTER
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shanghai Trend International Trade Co Ltd's FDA import refusal history?

Shanghai Trend International Trade Co Ltd (FEI: 3006979420) has 1 FDA import refusal record(s) in our database, spanning from 10/31/2008 to 10/31/2008.

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 Trend International Trade Co Ltd's FEI number is 3006979420.

What types of violations has Shanghai Trend International Trade Co Ltd received?

Shanghai Trend International Trade Co Ltd has been cited for 2 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 Trend International Trade Co Ltd come from?

All FDA import refusal data for Shanghai Trend International Trade 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.