Wuhan HNC Techology Co Ltd
⚠️ Moderate Risk
FEI: 3011258423 • Wuyi, Hubei • CHINA
FEI Number
3011258423
Location
Wuyi, Hubei
Country
CHINAAddress
Add: 3f Block7 Guannan Fuxing, Pharmaceut, Wuyi, Hubei, 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).
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.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
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).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/27/2017 | 89NHNLAMP, NON-HEATING, FOR ADJUNCTIVE USE IN PAIN THERAPY | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/27/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Los Angeles District Office (LOS-DO) | |
| 3/8/2013 | 89ONHPOWERED LASER NON-THEMAL INSTRUMENT WITH NON-HEATING EFFECT FOR ADJUNCTIVE USE IN PATH THERAPY | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Wuhan HNC Techology Co Ltd's FDA import refusal history?
Wuhan HNC Techology Co Ltd (FEI: 3011258423) has 3 FDA import refusal record(s) in our database, spanning from 3/8/2013 to 12/27/2017.
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. Wuhan HNC Techology Co Ltd's FEI number is 3011258423.
What types of violations has Wuhan HNC Techology Co Ltd received?
Wuhan HNC Techology Co Ltd has been cited for 6 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 Wuhan HNC Techology Co Ltd come from?
All FDA import refusal data for Wuhan HNC Techology 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.