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Sha Wan Win Yield Toys Limited

⚠️ Moderate Risk

FEI: 3003116197 • Shenzhen Buji Sha Wan • CHINA

FEI

FEI Number

3003116197

📍

Location

Shenzhen Buji Sha Wan

🇨🇳

Country

CHINA
🏢

Address

Shenzhen Buji Sha Wan, , Shenzhen Buji Sha Wan, , China

Moderate Risk

FDA Import Risk Assessment

27.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/6/2012
Latest Refusal
11/9/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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

1182×

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).

Refusal History

DateProductViolationsDivision
12/6/2012
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Chicago District Office (CHI-DO)
11/9/2012
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
118NOT LISTED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Sha Wan Win Yield Toys Limited's FDA import refusal history?

Sha Wan Win Yield Toys Limited (FEI: 3003116197) has 2 FDA import refusal record(s) in our database, spanning from 11/9/2012 to 12/6/2012.

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. Sha Wan Win Yield Toys Limited's FEI number is 3003116197.

What types of violations has Sha Wan Win Yield Toys Limited received?

Sha Wan Win Yield Toys 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 Sha Wan Win Yield Toys Limited come from?

All FDA import refusal data for Sha Wan Win Yield Toys 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.