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Startech International Ltd

⚠️ Moderate Risk

FEI: 3005236391 • Kwai Chung, New Territories • HONG KONG

FEI

FEI Number

3005236391

📍

Location

Kwai Chung, New Territories

🇭🇰

Country

HONG KONG
🏢

Address

42-48 Tai Lin Pai Road, , Kwai Chung, New Territories, Hong Kong

Moderate Risk

FDA Import Risk Assessment

29.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
9/13/2005
Latest Refusal
9/13/2005
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

1185×

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).

3415×

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
9/13/2005
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
San Francisco District Office (SAN-DO)
9/13/2005
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
San Francisco District Office (SAN-DO)
9/13/2005
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
San Francisco District Office (SAN-DO)
9/13/2005
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
San Francisco District Office (SAN-DO)
9/13/2005
76EFWTOOTHBRUSH, MANUAL
118NOT LISTED
341REGISTERED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Startech International Ltd's FDA import refusal history?

Startech International Ltd (FEI: 3005236391) has 5 FDA import refusal record(s) in our database, spanning from 9/13/2005 to 9/13/2005.

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. Startech International Ltd's FEI number is 3005236391.

What types of violations has Startech International Ltd received?

Startech International 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 Startech International Ltd come from?

All FDA import refusal data for Startech International 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.