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Zhejiang Menglei Import And Export

⚠️ Moderate Risk

FEI: 3006213621 • Yi Wuyi Wu • CHINA

FEI

FEI Number

3006213621

📍

Location

Yi Wuyi Wu

🇨🇳

Country

CHINA
🏢

Address

Co Ltd.No 132 Wu Ai Rd, , Yi Wuyi Wu, , China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/3/2011
Latest Refusal
10/3/2011
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
10/3/2011
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
235NOT IMPACT
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Zhejiang Menglei Import And Export's FDA import refusal history?

Zhejiang Menglei Import And Export (FEI: 3006213621) has 1 FDA import refusal record(s) in our database, spanning from 10/3/2011 to 10/3/2011.

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. Zhejiang Menglei Import And Export's FEI number is 3006213621.

What types of violations has Zhejiang Menglei Import And Export received?

Zhejiang Menglei Import And Export 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 Zhejiang Menglei Import And Export come from?

All FDA import refusal data for Zhejiang Menglei Import And 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.