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ZHENGZHOU SHUNDAO TRADING CO., LTD

⚠️ Moderate Risk

FEI: 3032638912 • Xzn • CHINA

FEI

FEI Number

3032638912

📍

Location

Xzn

🇨🇳

Country

CHINA
🏢

Address

(Spb-A)Room 212, Meiyibusiness, No, , Xzn, , China

Moderate Risk

FDA Import Risk Assessment

39.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/4/2024
Latest Refusal
12/4/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
77.6×20%
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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
12/4/2024
86HQZFRAME, SPECTACLE
118NOT LISTED
3280FRNMFGREG
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is ZHENGZHOU SHUNDAO TRADING CO., LTD's FDA import refusal history?

ZHENGZHOU SHUNDAO TRADING CO., LTD (FEI: 3032638912) has 1 FDA import refusal record(s) in our database, spanning from 12/4/2024 to 12/4/2024.

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. ZHENGZHOU SHUNDAO TRADING CO., LTD's FEI number is 3032638912.

What types of violations has ZHENGZHOU SHUNDAO TRADING CO., LTD received?

ZHENGZHOU SHUNDAO TRADING 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 ZHENGZHOU SHUNDAO TRADING CO., LTD come from?

All FDA import refusal data for ZHENGZHOU SHUNDAO TRADING 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.