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Suntek Shengke Trading Ltd

⚠️ Moderate Risk

FEI: 3008586580 • Kowloon • HONG KONG

FEI

FEI Number

3008586580

📍

Location

Kowloon

🇭🇰

Country

HONG KONG
🏢

Address

34-9 Pacific Trade 2 Hing Rd, , Kowloon, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

29.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/31/2010
Latest Refusal
12/31/2010
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
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

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).

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

751×

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
12/31/2010
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
341REGISTERED
508NO 510(K)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Suntek Shengke Trading Ltd's FDA import refusal history?

Suntek Shengke Trading Ltd (FEI: 3008586580) has 1 FDA import refusal record(s) in our database, spanning from 12/31/2010 to 12/31/2010.

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. Suntek Shengke Trading Ltd's FEI number is 3008586580.

What types of violations has Suntek Shengke Trading Ltd received?

Suntek Shengke Trading Ltd has been cited for 3 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 Suntek Shengke Trading Ltd come from?

All FDA import refusal data for Suntek Shengke Trading 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.