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GUANGZHOU SHANGSHI COSMETICS CO

⚠️ Moderate Risk

FEI: 3030748461 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3030748461

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

No. 2 North Street, Baiyun District, Guangzhou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

34.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/16/2024
Latest Refusal
8/16/2024
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
71.6×20%
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
8/16/2024
95RHLLASER THERAPY PRODUCT
118NOT LISTED
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is GUANGZHOU SHANGSHI COSMETICS CO's FDA import refusal history?

GUANGZHOU SHANGSHI COSMETICS CO (FEI: 3030748461) has 1 FDA import refusal record(s) in our database, spanning from 8/16/2024 to 8/16/2024.

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 SHANGSHI COSMETICS CO's FEI number is 3030748461.

What types of violations has GUANGZHOU SHANGSHI COSMETICS CO received?

GUANGZHOU SHANGSHI COSMETICS CO 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 GUANGZHOU SHANGSHI COSMETICS CO come from?

All FDA import refusal data for GUANGZHOU SHANGSHI COSMETICS 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.