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HEFEI SHIWUSHUANG ELECTRONIC COMMERCE CO. LTD

✅ Low Risk

FEI: 3016311281 • Hefei • CHINA

FEI

FEI Number

3016311281

📍

Location

Hefei

🇨🇳

Country

CHINA
🏢

Address

Building 21 Room 603, Baohe District; Phase I Baoneng City Baoneng City, Hefei, , 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
2/18/2020
Latest Refusal
2/18/2020
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
2/18/2020
86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION)
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is HEFEI SHIWUSHUANG ELECTRONIC COMMERCE CO. LTD's FDA import refusal history?

HEFEI SHIWUSHUANG ELECTRONIC COMMERCE CO. LTD (FEI: 3016311281) has 1 FDA import refusal record(s) in our database, spanning from 2/18/2020 to 2/18/2020.

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. HEFEI SHIWUSHUANG ELECTRONIC COMMERCE CO. LTD's FEI number is 3016311281.

What types of violations has HEFEI SHIWUSHUANG ELECTRONIC COMMERCE CO. LTD received?

HEFEI SHIWUSHUANG ELECTRONIC COMMERCE 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 HEFEI SHIWUSHUANG ELECTRONIC COMMERCE CO. LTD come from?

All FDA import refusal data for HEFEI SHIWUSHUANG ELECTRONIC COMMERCE 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.