Chen Yu Hardware F
⚠️ Moderate Risk
FEI: 3011074673 • Shatou • 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
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2015 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 11/20/2014 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 11/20/2014 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 126FAILS STD | New Orleans District Office (NOL-DO) |
| 11/20/2014 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 47NON STD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Chen Yu Hardware F's FDA import refusal history?
Chen Yu Hardware F (FEI: 3011074673) has 4 FDA import refusal record(s) in our database, spanning from 11/20/2014 to 1/16/2015.
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. Chen Yu Hardware F's FEI number is 3011074673.
What types of violations has Chen Yu Hardware F received?
Chen Yu Hardware F has been cited for 2 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 Chen Yu Hardware F come from?
All FDA import refusal data for Chen Yu Hardware F 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.