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Shenzhen Kingyield Technology Co Ltd

⚠️ Moderate Risk

FEI: 3007844485 • Gua • CHINA

FEI

FEI Number

3007844485

📍

Location

Gua

🇨🇳

Country

CHINA
🏢

Address

Sec C1 C2 Fuhai Industrial Zone Fuhai, , Gua, , China

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/27/2011
Latest Refusal
6/27/2011
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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).

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
6/27/2011
62GBY99ANTI-INFLAMMATORY N.E.C.
118NOT LISTED
75UNAPPROVED
Seattle District Office (SEA-DO)
6/27/2011
62GBY99ANTI-INFLAMMATORY N.E.C.
118NOT LISTED
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Shenzhen Kingyield Technology Co Ltd's FDA import refusal history?

Shenzhen Kingyield Technology Co Ltd (FEI: 3007844485) has 2 FDA import refusal record(s) in our database, spanning from 6/27/2011 to 6/27/2011.

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. Shenzhen Kingyield Technology Co Ltd's FEI number is 3007844485.

What types of violations has Shenzhen Kingyield Technology Co Ltd received?

Shenzhen Kingyield Technology Co 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 Shenzhen Kingyield Technology Co Ltd come from?

All FDA import refusal data for Shenzhen Kingyield Technology 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.