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Yinzhou Kada Industry Co Ltd

✅ Low Risk

FEI: 3006419036 • Ningbo • CHINA

FEI

FEI Number

3006419036

📍

Location

Ningbo

🇨🇳

Country

CHINA
🏢

Address

Hu Xi Gao Qiao District, , Ningbo, , China

Low Risk

FDA Import Risk Assessment

19.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
2/11/2009
Latest Refusal
2/11/2009
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

3412×

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
2/11/2009
89IMEPACK, HOT OR COLD, REUSEABLE
341REGISTERED
Los Angeles District Office (LOS-DO)
2/11/2009
89IMEPACK, HOT OR COLD, REUSEABLE
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Yinzhou Kada Industry Co Ltd's FDA import refusal history?

Yinzhou Kada Industry Co Ltd (FEI: 3006419036) has 2 FDA import refusal record(s) in our database, spanning from 2/11/2009 to 2/11/2009.

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. Yinzhou Kada Industry Co Ltd's FEI number is 3006419036.

What types of violations has Yinzhou Kada Industry Co Ltd received?

Yinzhou Kada 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 Yinzhou Kada Industry Co Ltd come from?

All FDA import refusal data for Yinzhou Kada 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.