Guangzhou BeautySlim Technology Co., LTD
⚠️ Moderate Risk
FEI: 3009597830 • Guangzhou City, Guangdong • CHINA
FEI Number
3009597830
Location
Guangzhou City, Guangdong
Country
CHINAAddress
Room 402 Shangyi Building, No. 3 School North Road, Guangzhou City, Guangdong, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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).
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
Frequently Asked Questions
What is Guangzhou BeautySlim Technology Co., LTD's FDA import refusal history?
Guangzhou BeautySlim Technology Co., LTD (FEI: 3009597830) has 1 FDA import refusal record(s) in our database, spanning from 7/20/2012 to 7/20/2012.
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 BeautySlim Technology Co., LTD's FEI number is 3009597830.
What types of violations has Guangzhou BeautySlim Technology Co., LTD received?
Guangzhou BeautySlim Technology 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 BeautySlim Technology Co., LTD come from?
All FDA import refusal data for Guangzhou BeautySlim Technology 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.