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LEADING HARDWARE (NINGBO) MACHINERY MFG. CO., LTD

⚠️ Moderate Risk

FEI: 3007675967 • Ningbo, Zhejiang • CHINA

FEI

FEI Number

3007675967

📍

Location

Ningbo, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Venture Investment Centre, , Ningbo, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
1/24/2013
Latest Refusal
1/8/2013
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2312×

LENS CERT

The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.

2351×

NOT IMPACT

The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.

Refusal History

DateProductViolationsDivision
1/24/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
San Francisco District Office (SAN-DO)
1/8/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
San Francisco District Office (SAN-DO)
1/8/2013
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
231LENS CERT
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is LEADING HARDWARE (NINGBO) MACHINERY MFG. CO., LTD's FDA import refusal history?

LEADING HARDWARE (NINGBO) MACHINERY MFG. CO., LTD (FEI: 3007675967) has 3 FDA import refusal record(s) in our database, spanning from 1/8/2013 to 1/24/2013.

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. LEADING HARDWARE (NINGBO) MACHINERY MFG. CO., LTD's FEI number is 3007675967.

What types of violations has LEADING HARDWARE (NINGBO) MACHINERY MFG. CO., LTD received?

LEADING HARDWARE (NINGBO) MACHINERY MFG. 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 LEADING HARDWARE (NINGBO) MACHINERY MFG. CO., LTD come from?

All FDA import refusal data for LEADING HARDWARE (NINGBO) MACHINERY MFG. 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.