Gateway Trading
⚠️ Moderate Risk
FEI: 3006541454 • Guangzhou • CHINA
FEI Number
3006541454
Location
Guangzhou
Country
CHINAAddress
91st Yunxiao Road Ste 301, , 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
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.
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.
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).
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
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).
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/16/2018 | 53CG99OTHER EYE MAKEUP PREPARATIONS, N.E.C. | 474COSMETLBLG | Division of Southeast Imports (DSEI) |
| 1/18/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 483DRUG NAME | Division of Southeast Imports (DSEI) |
| 1/18/2008 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 64ABL20TRICLOSAN (DISINFECTANT) | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE) | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 53CG02EYELINER (EYE MAKEUP PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 1/18/2008 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | Division of Southeast Imports (DSEI) | |
| 12/17/2007 | 85HHDPAD, MENSTRUAL, UNSCENTED | Division of Southeast Imports (DSEI) | |
| 12/17/2007 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Gateway Trading's FDA import refusal history?
Gateway Trading (FEI: 3006541454) has 15 FDA import refusal record(s) in our database, spanning from 12/17/2007 to 5/16/2018.
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. Gateway Trading's FEI number is 3006541454.
What types of violations has Gateway Trading received?
Gateway Trading has been cited for 10 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 Gateway Trading come from?
All FDA import refusal data for Gateway Trading 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.