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TAIZHOU YIZHAN OPTICAL GLASSES CO LTD

✅ Low Risk

FEI: 3021343301 • Donghai First Avenue, Zhejiang • CHINA

FEI

FEI Number

3021343301

📍

Location

Donghai First Avenue, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Building 5 Unit No 101, Duqiao District; Linhai City Taizhou City, Donghai First Avenue, Zhejiang, China

Low Risk

FDA Import Risk Assessment

21.2
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
12/13/2022
Latest Refusal
12/13/2022
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
24.4×20%
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
12/13/2022
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is TAIZHOU YIZHAN OPTICAL GLASSES CO LTD's FDA import refusal history?

TAIZHOU YIZHAN OPTICAL GLASSES CO LTD (FEI: 3021343301) has 1 FDA import refusal record(s) in our database, spanning from 12/13/2022 to 12/13/2022.

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. TAIZHOU YIZHAN OPTICAL GLASSES CO LTD's FEI number is 3021343301.

What types of violations has TAIZHOU YIZHAN OPTICAL GLASSES CO LTD received?

TAIZHOU YIZHAN OPTICAL 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 TAIZHOU YIZHAN OPTICAL GLASSES CO LTD come from?

All FDA import refusal data for TAIZHOU YIZHAN OPTICAL 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.