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Foshan Yuxuan Gong Technology And Development Co

✅ Low Risk

FEI: 3010682437 • Foshan City, Yandongsheng • CHINA

FEI

FEI Number

3010682437

📍

Location

Foshan City, Yandongsheng

🇨🇳

Country

CHINA
🏢

Address

51 Zumiaolu, , Foshan City, Yandongsheng, China

Low Risk

FDA Import Risk Assessment

19.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
3/19/2014
Latest Refusal
3/19/2014
Earliest Refusal

Score Breakdown

Violation Severity
36.7×40%
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

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

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).

4841×

DV NAME

The article appears to be a device and its labeling fails to bear the proprietary or established name.

Refusal History

DateProductViolationsDivision
3/19/2014
89ISAMASSAGER, THERAPEUTIC, ELECTRIC
3260NO ENGLISH
341REGISTERED
484DV NAME
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Foshan Yuxuan Gong Technology And Development Co's FDA import refusal history?

Foshan Yuxuan Gong Technology And Development Co (FEI: 3010682437) has 1 FDA import refusal record(s) in our database, spanning from 3/19/2014 to 3/19/2014.

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. Foshan Yuxuan Gong Technology And Development Co's FEI number is 3010682437.

What types of violations has Foshan Yuxuan Gong Technology And Development Co received?

Foshan Yuxuan Gong Technology And Development Co 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 Foshan Yuxuan Gong Technology And Development Co come from?

All FDA import refusal data for Foshan Yuxuan Gong Technology And Development Co 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.