GZ BEAUTYLINE INTERNATIONAL CO L
⚠️ Moderate Risk
FEI: 3014039465 • Guangzhou • CHINA
FEI Number
3014039465
Location
Guangzhou
Country
CHINAAddress
Room 30 Floor5 Eton Apa, , 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
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 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).
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/29/2019 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 10/22/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | Division of Southeast Imports (DSEI) | |
| 10/19/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 473LABELING | Division of Southeast Imports (DSEI) |
| 10/12/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GZ BEAUTYLINE INTERNATIONAL CO L's FDA import refusal history?
GZ BEAUTYLINE INTERNATIONAL CO L (FEI: 3014039465) has 4 FDA import refusal record(s) in our database, spanning from 10/12/2018 to 1/29/2019.
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. GZ BEAUTYLINE INTERNATIONAL CO L's FEI number is 3014039465.
What types of violations has GZ BEAUTYLINE INTERNATIONAL CO L received?
GZ BEAUTYLINE INTERNATIONAL CO L has been cited for 6 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 GZ BEAUTYLINE INTERNATIONAL CO L come from?
All FDA import refusal data for GZ BEAUTYLINE INTERNATIONAL CO L 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.