HUIZHOU AOGE ENTERPRISE CO LTD
⚠️ Moderate Risk
FEI: 3012405703 • Huizhou • CHINA
FEI Number
3012405703
Location
Huizhou
Country
CHINAAddress
Huizhou, City With iTs Pliasant Factory, Huizhou, , 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
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.
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).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
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.
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.
TPNICWARN
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act because it is a tobacco product that appears to be misbranded under section 903(a)(7)(B) in that it is sold or distributed in violation of regulations prescribed under 906(d), namely its package fails to bear the required warning statement "WARNING: This product contains nicotine. Nicotine is an addictive chemical." Or if applicable the required statement "This product is made from tobacco."
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.
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).
TPLACKFIRM
This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product manufacturer, packer or distributor.
TPLKUSSLLB
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/19/2020 | 98MCA01E-LIQUID | Division of Southeast Imports (DSEI) | |
| 7/27/2020 | 80LKBPAD, ALCOHOL, DEVICE DISINFECTANT | Division of Southeast Imports (DSEI) | |
| 9/10/2019 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Division of West Coast Imports (DWCI) | |
| 4/4/2018 | 79BWAUNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 10/10/2017 | 53YY02COSMETIC BRUSH (OTHER COSMETIC AND COSMETIC PRODUCTS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 10/10/2017 | 76EFSUNIT, ORAL IRRIGATION | Division of Southeast Imports (DSEI) | |
| 10/10/2017 | 74DRXELECTRODE, ELECTROCARDIOGRAPH | Division of Southeast Imports (DSEI) | |
| 10/10/2017 | 89MRIORTHOSIS, TRUNCAL/ORTHOSIS, LIMB | Division of Southeast Imports (DSEI) | |
| 8/9/2017 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/9/2017 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 8/9/2017 | 63RAY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | Division of Southeast Imports (DSEI) | |
| 7/17/2017 | 53IC01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HUIZHOU AOGE ENTERPRISE CO LTD's FDA import refusal history?
HUIZHOU AOGE ENTERPRISE CO LTD (FEI: 3012405703) has 12 FDA import refusal record(s) in our database, spanning from 7/17/2017 to 10/19/2020.
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. HUIZHOU AOGE ENTERPRISE CO LTD's FEI number is 3012405703.
What types of violations has HUIZHOU AOGE ENTERPRISE CO LTD received?
HUIZHOU AOGE ENTERPRISE CO LTD has been cited for 12 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 HUIZHOU AOGE ENTERPRISE CO LTD come from?
All FDA import refusal data for HUIZHOU AOGE ENTERPRISE 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.