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START LINK ELECTRICAL (SHENZHEN)

⚠️ Moderate Risk

FEI: 3012625030 • Shenzhen • CHINA

FEI

FEI Number

3012625030

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

10 Ruiyuan Road, Songshan Industrial Area, Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

25.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
1
Unique Violations
3/28/2018
Latest Refusal
3/28/2018
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
3/28/2018
73KFZHUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
341REGISTERED
Division of West Coast Imports (DWCI)
3/28/2018
73KFZHUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
341REGISTERED
Division of West Coast Imports (DWCI)
3/28/2018
73KFZHUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
341REGISTERED
Division of West Coast Imports (DWCI)
3/28/2018
73KFZHUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
341REGISTERED
Division of West Coast Imports (DWCI)
3/28/2018
73KFZHUMIDIFIER, NON-DIRECT PATIENT INTERFACE (HOME-USE)
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is START LINK ELECTRICAL (SHENZHEN)'s FDA import refusal history?

START LINK ELECTRICAL (SHENZHEN) (FEI: 3012625030) has 5 FDA import refusal record(s) in our database, spanning from 3/28/2018 to 3/28/2018.

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. START LINK ELECTRICAL (SHENZHEN)'s FEI number is 3012625030.

What types of violations has START LINK ELECTRICAL (SHENZHEN) received?

START LINK ELECTRICAL (SHENZHEN) 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 START LINK ELECTRICAL (SHENZHEN) come from?

All FDA import refusal data for START LINK ELECTRICAL (SHENZHEN) 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.