Hsy Industrial Ltd
⚠️ Moderate Risk
FEI: 3008263898 • Guangdong • CHINA
FEI Number
3008263898
Location
Guangdong
Country
CHINAAddress
Xili Town Nanshan Dist, , Guangdong, , 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/6/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/6/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/6/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/6/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 1/6/2014 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Hsy Industrial Ltd's FDA import refusal history?
Hsy Industrial Ltd (FEI: 3008263898) has 5 FDA import refusal record(s) in our database, spanning from 1/6/2014 to 1/6/2014.
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. Hsy Industrial Ltd's FEI number is 3008263898.
What types of violations has Hsy Industrial Ltd received?
Hsy Industrial Ltd has been cited for 1 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 Hsy Industrial Ltd come from?
All FDA import refusal data for Hsy Industrial 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.