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Wayear International Limited

⚠️ Moderate Risk

FEI: 3004060189 • Tsim Sha Tsui, Kowloon • HONG KONG

FEI

FEI Number

3004060189

📍

Location

Tsim Sha Tsui, Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

75 Mody Road, , Tsim Sha Tsui, Kowloon, Hong Kong

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/30/2008
Latest Refusal
7/30/2008
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
7/30/2008
95L22LASER PRODUCT FOR NON-MEDICAL USE
47NON STD
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Wayear International Limited's FDA import refusal history?

Wayear International Limited (FEI: 3004060189) has 1 FDA import refusal record(s) in our database, spanning from 7/30/2008 to 7/30/2008.

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. Wayear International Limited's FEI number is 3004060189.

What types of violations has Wayear International Limited received?

Wayear International Limited 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 Wayear International Limited come from?

All FDA import refusal data for Wayear International 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.