Henan Sunhe Electronic Technology Co Ltd
⚠️ Moderate Risk
FEI: 3014114363 • Zhengzhou, Henan • CHINA
FEI Number
3014114363
Location
Zhengzhou, Henan
Country
CHINAAddress
Build 5.Jinyin, Modern City, Zhengzhou, Henan, 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).
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.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/22/2018 | 76EEGHEAT SOURCE FOR BLEACHING TEETH | Division of Southeast Imports (DSEI) | |
| 5/1/2018 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 3/26/2018 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Henan Sunhe Electronic Technology Co Ltd's FDA import refusal history?
Henan Sunhe Electronic Technology Co Ltd (FEI: 3014114363) has 3 FDA import refusal record(s) in our database, spanning from 3/26/2018 to 5/22/2018.
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. Henan Sunhe Electronic Technology Co Ltd's FEI number is 3014114363.
What types of violations has Henan Sunhe Electronic Technology Co Ltd received?
Henan Sunhe Electronic Technology Co Ltd 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 Henan Sunhe Electronic Technology Co Ltd come from?
All FDA import refusal data for Henan Sunhe Electronic Technology 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.