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Yangaiqun

✅ Low Risk

FEI: 3010235267 • Geuangzhougeuangzhou • CHINA

FEI

FEI Number

3010235267

📍

Location

Geuangzhougeuangzhou

🇨🇳

Country

CHINA
🏢

Address

2-F Hetting West Rd, , Geuangzhougeuangzhou, , China

Low Risk

FDA Import Risk Assessment

23.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
7/10/2013
Latest Refusal
7/10/2013
Earliest Refusal

Score Breakdown

Violation Severity
46.7×40%
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

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).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

5081×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

DateProductViolationsDivision
7/10/2013
89LYGMASSAGER, THERAPEUTIC, MANUAL
118NOT LISTED
333LACKS FIRM
508NO 510(K)
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Yangaiqun's FDA import refusal history?

Yangaiqun (FEI: 3010235267) has 1 FDA import refusal record(s) in our database, spanning from 7/10/2013 to 7/10/2013.

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. Yangaiqun's FEI number is 3010235267.

What types of violations has Yangaiqun received?

Yangaiqun has been cited for 3 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 Yangaiqun come from?

All FDA import refusal data for Yangaiqun 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.