Guangzhou Beauty Cosmetic Co., Ltd
⚠️ Moderate Risk
FEI: 3013614541 • Guangzhou, Guangdong • CHINA
FEI Number
3013614541
Location
Guangzhou, Guangdong
Country
CHINAAddress
Shima Village, Baiyun Districtg, 18 Taoyuan West 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
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/5/2019 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 3/5/2019 | 63RAJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Guangzhou Beauty Cosmetic Co., Ltd's FDA import refusal history?
Guangzhou Beauty Cosmetic Co., Ltd (FEI: 3013614541) has 2 FDA import refusal record(s) in our database, spanning from 3/5/2019 to 3/5/2019.
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 Beauty Cosmetic Co., Ltd's FEI number is 3013614541.
What types of violations has Guangzhou Beauty Cosmetic Co., Ltd received?
Guangzhou Beauty Cosmetic Co., Ltd has been cited for 5 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 Beauty Cosmetic Co., Ltd come from?
All FDA import refusal data for Guangzhou Beauty Cosmetic 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.