HIZHOU AOGE ENTERPRISE COL TLD
⚠️ Moderate Risk
FEI: 3013351940 • Huizhou • CHINA
FEI Number
3013351940
Location
Huizhou
Country
CHINAAddress
Huizhou, City With iTs P, 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
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).
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/5/2021 | 78EZQPOUCH, COLOSTOMY | Division of Southeast Imports (DSEI) | |
| 12/9/2020 | 85NUCLUBRICANT, PATIENT, VAGINAL, LATEX COMPATIBLE | Division of Southeast Imports (DSEI) | |
| 9/9/2020 | 98LAA06E-CIGAR, KIT | 3851TPLACKFIRM | Division of Southeast Imports (DSEI) |
| 9/9/2020 | 73CCQNEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HIZHOU AOGE ENTERPRISE COL TLD's FDA import refusal history?
HIZHOU AOGE ENTERPRISE COL TLD (FEI: 3013351940) has 4 FDA import refusal record(s) in our database, spanning from 9/9/2020 to 5/5/2021.
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. HIZHOU AOGE ENTERPRISE COL TLD's FEI number is 3013351940.
What types of violations has HIZHOU AOGE ENTERPRISE COL TLD received?
HIZHOU AOGE ENTERPRISE COL TLD 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 HIZHOU AOGE ENTERPRISE COL TLD come from?
All FDA import refusal data for HIZHOU AOGE ENTERPRISE COL TLD 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.