ImportRefusal LogoImportRefusal

Yamada Electric (Hong Kong) Company Limited

✅ Low Risk

FEI: 1000230920 • Aberdeen, Hong Kong • HONG KONG

FEI

FEI Number

1000230920

📍

Location

Aberdeen, Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

20, Wong Chuk Hang Road, , Aberdeen, Hong Kong, Hong Kong

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
8/9/2007
Latest Refusal
8/9/2007
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
8/9/2007
76JEQTOOTHBRUSH, POWERED
118NOT LISTED
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Yamada Electric (Hong Kong) Company Limited's FDA import refusal history?

Yamada Electric (Hong Kong) Company Limited (FEI: 1000230920) has 1 FDA import refusal record(s) in our database, spanning from 8/9/2007 to 8/9/2007.

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. Yamada Electric (Hong Kong) Company Limited's FEI number is 1000230920.

What types of violations has Yamada Electric (Hong Kong) Company Limited received?

Yamada Electric (Hong Kong) Company Limited 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 Yamada Electric (Hong Kong) Company Limited come from?

All FDA import refusal data for Yamada Electric (Hong Kong) Company Limited 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.