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Guangzhou Yushu Health Industry Co., Ltd.

⚠️ Moderate Risk

FEI: 3022819873 • Guangzhou, Cn-Gd • CHINA

FEI

FEI Number

3022819873

📍

Location

Guangzhou, Cn-Gd

🇨🇳

Country

CHINA
🏢

Address

Room 701 2, Hongyi Business Center, No. 6 Fenggang Road, Renhe Town, Baiyun District, Guangzhou, Cn-Gd, China

Moderate Risk

FDA Import Risk Assessment

43.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
10/1/2025
Latest Refusal
10/1/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
94.5×20%
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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

35001×

RXLABEL

The labeling fails to bear, at a minimum, the symbol "RX Only".

Refusal History

DateProductViolationsDivision
10/1/2025
62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
118NOT LISTED
3280FRNMFGREG
3500RXLABEL
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Guangzhou Yushu Health Industry Co., Ltd.'s FDA import refusal history?

Guangzhou Yushu Health Industry Co., Ltd. (FEI: 3022819873) has 1 FDA import refusal record(s) in our database, spanning from 10/1/2025 to 10/1/2025.

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. Guangzhou Yushu Health Industry Co., Ltd.'s FEI number is 3022819873.

What types of violations has Guangzhou Yushu Health Industry Co., Ltd. received?

Guangzhou Yushu Health Industry Co., Ltd. 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 Guangzhou Yushu Health Industry Co., Ltd. come from?

All FDA import refusal data for Guangzhou Yushu Health Industry 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.