Guangzho Prebeauty Electronic Tech.
⚠️ Moderate Risk
FEI: 3011819902 • Guangzhou • CHINA
FEI Number
3011819902
Location
Guangzhou
Country
CHINAAddress
NO. 22 Rongxi Industrial Streetbaiyun, , Guangzhou, , 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
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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.
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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/9/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | 471CSTIC LBLG | Division of West Coast Imports (DWCI) |
| 11/9/2015 | 53HG05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS) | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 89NGXSTIMULATOR, MUSCLE, POWERED, FOR MUSCLE CONDITIONING | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 79PBXMASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 80KMHSTERILIZER, DRY HEAT | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 79PBXMASSAGER, VACUUM, RADIO FREQUENCY INDUCED HEAT | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 80FLESTERILIZER, STEAM | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 80JOLCATHETER AND TIP, SUCTION | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 77KCNEAR WICK | Division of West Coast Imports (DWCI) | |
| 11/9/2015 | 89ILYLAMP, INFRARED, THERAPEUTIC HEATING | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Guangzho Prebeauty Electronic Tech.'s FDA import refusal history?
Guangzho Prebeauty Electronic Tech. (FEI: 3011819902) has 16 FDA import refusal record(s) in our database, spanning from 11/9/2015 to 11/9/2015.
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. Guangzho Prebeauty Electronic Tech.'s FEI number is 3011819902.
What types of violations has Guangzho Prebeauty Electronic Tech. received?
Guangzho Prebeauty Electronic Tech. has been cited for 14 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 Guangzho Prebeauty Electronic Tech. come from?
All FDA import refusal data for Guangzho Prebeauty Electronic Tech. 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.