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ZHUJI YINUO WEITE KNITTING CO LTD

⚠️ Moderate Risk

FEI: 3035219916 • Zhuji • CHINA

FEI

FEI Number

3035219916

📍

Location

Zhuji

🇨🇳

Country

CHINA
🏢

Address

No. 533 Xiajiang Road, , Zhuji, , China

Moderate Risk

FDA Import Risk Assessment

38.0
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
6/12/2025
Latest Refusal
4/14/2025
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
17.7×30%
Recency
73.5×20%
Frequency
20.0×10%
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

3412×

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).

2351×

NOT IMPACT

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

Refusal History

DateProductViolationsDivision
6/12/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
235NOT IMPACT
341REGISTERED
Division of Southwest Imports (DSWI)
4/14/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is ZHUJI YINUO WEITE KNITTING CO LTD's FDA import refusal history?

ZHUJI YINUO WEITE KNITTING CO LTD (FEI: 3035219916) has 2 FDA import refusal record(s) in our database, spanning from 4/14/2025 to 6/12/2025.

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. ZHUJI YINUO WEITE KNITTING CO LTD's FEI number is 3035219916.

What types of violations has ZHUJI YINUO WEITE KNITTING CO LTD received?

ZHUJI YINUO WEITE KNITTING 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 ZHUJI YINUO WEITE KNITTING CO LTD come from?

All FDA import refusal data for ZHUJI YINUO WEITE KNITTING 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.