Race Beauty Equipment Co., Ltd.
⚠️ Moderate Risk
FEI: 3008361566 • Guangzhou, Guangdong • CHINA
FEI Number
3008361566
Location
Guangzhou, Guangdong
Country
CHINAAddress
Jiulong Industrial Park, No 23 Fenghuang 4 Rd, Guangzhou, 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/6/2012 | 89NZFMASSAGER, COSMETIC, STATIC ELECTRICITY-EMITTING | Cincinnati District Office (CIN-DO) | |
| 7/12/2012 | 84NYXSTIMULATOR, ELECTRICAL, TRANSCUTANEOUS, WITH LIMTED OUTPUT, FOR AESTHETIC PURPOSES | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Race Beauty Equipment Co., Ltd.'s FDA import refusal history?
Race Beauty Equipment Co., Ltd. (FEI: 3008361566) has 2 FDA import refusal record(s) in our database, spanning from 7/12/2012 to 11/6/2012.
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. Race Beauty Equipment Co., Ltd.'s FEI number is 3008361566.
What types of violations has Race Beauty Equipment Co., Ltd. received?
Race Beauty Equipment Co., Ltd. has been cited for 4 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 Race Beauty Equipment Co., Ltd. come from?
All FDA import refusal data for Race Beauty Equipment 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.