YAORAN ELECTRONIC TECHNOLOGY CO
⚠️ Moderate Risk
FEI: 3013422398 • Huizhou • CHINA
FEI Number
3013422398
Location
Huizhou
Country
CHINAAddress
Yaoyu Group, Zone Dongmi, 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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
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 |
|---|---|---|---|
| 9/22/2025 | 62CIL41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 9/22/2025 | 62CIL41MINOXIDIL (ANTI-HYPERTENSIVE) | Division of Southeast Imports (DSEI) | |
| 9/13/2021 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 473LABELING | Division of Southeast Imports (DSEI) |
| 6/11/2020 | 98MAA15ENDS FILTER | Division of Northern Border Imports (DNBI) | |
| 5/29/2018 | 76JEQTOOTHBRUSH, POWERED | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is YAORAN ELECTRONIC TECHNOLOGY CO's FDA import refusal history?
YAORAN ELECTRONIC TECHNOLOGY CO (FEI: 3013422398) has 5 FDA import refusal record(s) in our database, spanning from 5/29/2018 to 9/22/2025.
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. YAORAN ELECTRONIC TECHNOLOGY CO's FEI number is 3013422398.
What types of violations has YAORAN ELECTRONIC TECHNOLOGY CO received?
YAORAN ELECTRONIC TECHNOLOGY CO has been cited for 7 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 YAORAN ELECTRONIC TECHNOLOGY CO come from?
All FDA import refusal data for YAORAN ELECTRONIC TECHNOLOGY CO 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.