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L & W Company Ltd

⚠️ Moderate Risk

FEI: 3004001824 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3004001824

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

81 Taojinbeilu, Conghua, Guangzhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

31.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
7/12/2005
Latest Refusal
7/12/2005
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

3416×

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).

5082×

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.

Refusal History

DateProductViolationsDivision
7/12/2005
79HRMMICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
7/12/2005
85MOKVAGINOSCOPE AND ACCESSORIES
341REGISTERED
508NO 510(K)
Los Angeles District Office (LOS-DO)
7/12/2005
85MOKVAGINOSCOPE AND ACCESSORIES
341REGISTERED
Los Angeles District Office (LOS-DO)
7/12/2005
85MOKVAGINOSCOPE AND ACCESSORIES
341REGISTERED
Los Angeles District Office (LOS-DO)
7/12/2005
79HRMMICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC
341REGISTERED
Los Angeles District Office (LOS-DO)
7/12/2005
79HRMMICROSCOPE, OPERATING & ACCESSORIES, AC-POWERED, OPHTHALMIC
341REGISTERED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is L & W Company Ltd's FDA import refusal history?

L & W Company Ltd (FEI: 3004001824) has 6 FDA import refusal record(s) in our database, spanning from 7/12/2005 to 7/12/2005.

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. L & W Company Ltd's FEI number is 3004001824.

What types of violations has L & W Company Ltd received?

L & W Company 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 L & W Company Ltd come from?

All FDA import refusal data for L & W Company 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.