Huanic Corporation
⚠️ Moderate Risk
FEI: 3006230835 • Xian, Shanxi • CHINA
FEI Number
3006230835
Location
Xian, Shanxi
Country
CHINAAddress
No. 67 Jinye Road, Yanta, Xian, Shanxi, 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
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).
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 TAG
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 to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | Los Angeles District Office (LOS-DO) |
| 12/22/2014 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | Seattle District Office (SEA-DO) | |
| 4/27/2006 | 95L22LASER PRODUCT FOR NON-MEDICAL USE | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Huanic Corporation's FDA import refusal history?
Huanic Corporation (FEI: 3006230835) has 3 FDA import refusal record(s) in our database, spanning from 4/27/2006 to 11/3/2015.
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. Huanic Corporation's FEI number is 3006230835.
What types of violations has Huanic Corporation received?
Huanic Corporation has been cited for 4 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 Huanic Corporation come from?
All FDA import refusal data for Huanic Corporation 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.