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Shenzhen Longfei Import & Export

✅ Low Risk

FEI: 3004010672 • Fujian • CHINA

FEI

FEI Number

3004010672

📍

Location

Fujian

🇨🇳

Country

CHINA
🏢

Address

2/F Minxing Bld No190 817rd, , Fujian, , China

Low Risk

FDA Import Risk Assessment

19.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

2
Total Refusals
1
Unique Violations
8/23/2004
Latest Refusal
8/23/2004
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

3412×

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
8/23/2004
80LLIBED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
341REGISTERED
Los Angeles District Office (LOS-DO)
8/23/2004
80LLIBED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Shenzhen Longfei Import & Export's FDA import refusal history?

Shenzhen Longfei Import & Export (FEI: 3004010672) has 2 FDA import refusal record(s) in our database, spanning from 8/23/2004 to 8/23/2004.

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 Longfei Import & Export's FEI number is 3004010672.

What types of violations has Shenzhen Longfei Import & Export received?

Shenzhen Longfei Import & Export 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 Shenzhen Longfei Import & Export come from?

All FDA import refusal data for Shenzhen Longfei Import & Export 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.