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WUHAN MAXWAVE LASER TECHNOLOGY CO LTD

⚠️ Moderate Risk

FEI: 3017620476 • Wuhan Hubei Province • CHINA

FEI

FEI Number

3017620476

📍

Location

Wuhan Hubei Province

🇨🇳

Country

CHINA
🏢

Address

Rm2 Layer 1-2 Buildingb8 28th Str Leisure Busines, Center Panglong Cheng Economic Development Zone, Wuhan Hubei Province, , China

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/24/2023
Latest Refusal
5/24/2023
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
46.7×20%
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

2781×

NO TAG

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).

3441×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

Refusal History

DateProductViolationsDivision
5/24/2023
95RFFLASER WELDER, MATERIALS PROCESSING LASER PRODUCTS
278NO TAG
344WARNINGS
Division of Southwest Imports (DSWI)

Frequently Asked Questions

What is WUHAN MAXWAVE LASER TECHNOLOGY CO LTD's FDA import refusal history?

WUHAN MAXWAVE LASER TECHNOLOGY CO LTD (FEI: 3017620476) has 1 FDA import refusal record(s) in our database, spanning from 5/24/2023 to 5/24/2023.

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. WUHAN MAXWAVE LASER TECHNOLOGY CO LTD's FEI number is 3017620476.

What types of violations has WUHAN MAXWAVE LASER TECHNOLOGY CO LTD received?

WUHAN MAXWAVE LASER 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 WUHAN MAXWAVE LASER TECHNOLOGY CO LTD come from?

All FDA import refusal data for WUHAN MAXWAVE LASER 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.