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WENZHOU LUCHENG PLATING EQUIPMENT COMPANY

✅ Low Risk

FEI: 3018002580 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3018002580

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Plots No.8, Lucheng District, Wenzhou, Zhejiang, China

Low Risk

FDA Import Risk Assessment

18.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
5/6/2022
Latest Refusal
5/6/2022
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
12.3×20%
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).

Refusal History

DateProductViolationsDivision
5/6/2022
86HOISPECTACLE, MAGNIFYING
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is WENZHOU LUCHENG PLATING EQUIPMENT COMPANY's FDA import refusal history?

WENZHOU LUCHENG PLATING EQUIPMENT COMPANY (FEI: 3018002580) has 1 FDA import refusal record(s) in our database, spanning from 5/6/2022 to 5/6/2022.

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. WENZHOU LUCHENG PLATING EQUIPMENT COMPANY's FEI number is 3018002580.

What types of violations has WENZHOU LUCHENG PLATING EQUIPMENT COMPANY received?

WENZHOU LUCHENG PLATING EQUIPMENT COMPANY 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 WENZHOU LUCHENG PLATING EQUIPMENT COMPANY come from?

All FDA import refusal data for WENZHOU LUCHENG PLATING EQUIPMENT COMPANY 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.