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LINHAI YITUO GLASSES CO., LTD.

⚠️ Moderate Risk

FEI: 3030542847 • Taizhou, Zhejiang • CHINA

FEI

FEI Number

3030542847

📍

Location

Taizhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

4th Floor, No. 1-299 Songzhong Village, Duqiao; Town, Linhai City, Taizhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

32.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/20/2025
Latest Refusal
2/20/2025
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
82.0×20%
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

3411×

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).

Refusal History

DateProductViolationsDivision
2/20/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is LINHAI YITUO GLASSES CO., LTD.'s FDA import refusal history?

LINHAI YITUO GLASSES CO., LTD. (FEI: 3030542847) has 1 FDA import refusal record(s) in our database, spanning from 2/20/2025 to 2/20/2025.

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. LINHAI YITUO GLASSES CO., LTD.'s FEI number is 3030542847.

What types of violations has LINHAI YITUO GLASSES CO., LTD. received?

LINHAI YITUO GLASSES CO., LTD. has been cited for 1 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 LINHAI YITUO GLASSES CO., LTD. come from?

All FDA import refusal data for LINHAI YITUO GLASSES 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.