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Shezhen Ningchangtai Trade Develops Co., Ltd

✅ Low Risk

FEI: 3006796402 • Zhejiang • CHINA

FEI

FEI Number

3006796402

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Rm 401. No. 15 Lane 1 Zone Danxi Yiwu, , Zhejiang, , 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
7/9/2009
Latest Refusal
7/9/2009
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
7/9/2009
85OHHBREAST PUMP KIT
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shezhen Ningchangtai Trade Develops Co., Ltd's FDA import refusal history?

Shezhen Ningchangtai Trade Develops Co., Ltd (FEI: 3006796402) has 1 FDA import refusal record(s) in our database, spanning from 7/9/2009 to 7/9/2009.

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. Shezhen Ningchangtai Trade Develops Co., Ltd's FEI number is 3006796402.

What types of violations has Shezhen Ningchangtai Trade Develops Co., Ltd received?

Shezhen Ningchangtai Trade Develops 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 Shezhen Ningchangtai Trade Develops Co., Ltd come from?

All FDA import refusal data for Shezhen Ningchangtai Trade Develops 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.