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SHAOYANG

⚠️ Moderate Risk

FEI: 3018945397 • Zhoukou • CHINA

FEI

FEI Number

3018945397

📍

Location

Zhoukou

🇨🇳

Country

CHINA
🏢

Address

1005 Building, 2 Shanshu, Zhoukou, , China

Moderate Risk

FDA Import Risk Assessment

31.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/12/2023
Latest Refusal
10/12/2023
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
54.5×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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
10/12/2023
80FYDAPPARATUS, EXHAUST, SURGICAL
118NOT LISTED
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is SHAOYANG's FDA import refusal history?

SHAOYANG (FEI: 3018945397) has 1 FDA import refusal record(s) in our database, spanning from 10/12/2023 to 10/12/2023.

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. SHAOYANG's FEI number is 3018945397.

What types of violations has SHAOYANG received?

SHAOYANG 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 SHAOYANG come from?

All FDA import refusal data for SHAOYANG 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.