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ZHEJIANG INTERNATIONAL E-COMMERCE HOLDINGS CO.,LTD. WENZHOU BRANCH

⚠️ Moderate Risk

FEI: 3030800454 • Wenzhou, Zhejiang • CHINA

FEI

FEI Number

3030800454

📍

Location

Wenzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Zhanxin Building No. 58 Room 804, Liming Street Xiangyuan Road; Lucheng, Wenzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

34.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
3/24/2025
Latest Refusal
3/24/2025
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
70.0×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

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
3/24/2025
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
3280FRNMFGREG
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is ZHEJIANG INTERNATIONAL E-COMMERCE HOLDINGS CO.,LTD. WENZHOU BRANCH's FDA import refusal history?

ZHEJIANG INTERNATIONAL E-COMMERCE HOLDINGS CO.,LTD. WENZHOU BRANCH (FEI: 3030800454) has 1 FDA import refusal record(s) in our database, spanning from 3/24/2025 to 3/24/2025.

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. ZHEJIANG INTERNATIONAL E-COMMERCE HOLDINGS CO.,LTD. WENZHOU BRANCH's FEI number is 3030800454.

What types of violations has ZHEJIANG INTERNATIONAL E-COMMERCE HOLDINGS CO.,LTD. WENZHOU BRANCH received?

ZHEJIANG INTERNATIONAL E-COMMERCE HOLDINGS CO.,LTD. WENZHOU BRANCH 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 INTERNATIONAL E-COMMERCE HOLDINGS CO.,LTD. WENZHOU BRANCH come from?

All FDA import refusal data for ZHEJIANG INTERNATIONAL E-COMMERCE HOLDINGS CO.,LTD. WENZHOU BRANCH 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.