ImportRefusal LogoImportRefusal

Shaoxing Outdoor Fashion Co. Ltd

✅ Low Risk

FEI: 3011150257 • Shaoxing, Zhejiang • CHINA

FEI

FEI Number

3011150257

📍

Location

Shaoxing, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Modern Mansion NO. 276 Level 7, , Shaoxing, Zhejiang, China

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/29/2014
Latest Refusal
12/29/2014
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
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

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
12/29/2014
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Shaoxing Outdoor Fashion Co. Ltd's FDA import refusal history?

Shaoxing Outdoor Fashion Co. Ltd (FEI: 3011150257) has 1 FDA import refusal record(s) in our database, spanning from 12/29/2014 to 12/29/2014.

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. Shaoxing Outdoor Fashion Co. Ltd's FEI number is 3011150257.

What types of violations has Shaoxing Outdoor Fashion Co. Ltd received?

Shaoxing Outdoor Fashion 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 Shaoxing Outdoor Fashion Co. Ltd come from?

All FDA import refusal data for Shaoxing Outdoor Fashion 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.