GOLDEN SMART HOME TECHNOLOGY CORP.
⚠️ Moderate Risk
FEI: 3015188281 • Hsinchu City • TAIWAN
FEI Number
3015188281
Location
Hsinchu City
Country
TAIWANAddress
Hsinchu Science Park, Room 206; No. 47 Yuanqu 2nd Rd.; East Dist., Hsinchu City, , Taiwan
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/19/2024 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/19/2024 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/19/2024 | 74DXNSYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/19/2024 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GOLDEN SMART HOME TECHNOLOGY CORP.'s FDA import refusal history?
GOLDEN SMART HOME TECHNOLOGY CORP. (FEI: 3015188281) has 4 FDA import refusal record(s) in our database, spanning from 3/19/2024 to 3/19/2024.
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. GOLDEN SMART HOME TECHNOLOGY CORP.'s FEI number is 3015188281.
What types of violations has GOLDEN SMART HOME TECHNOLOGY CORP. received?
GOLDEN SMART HOME TECHNOLOGY CORP. 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 GOLDEN SMART HOME TECHNOLOGY CORP. come from?
All FDA import refusal data for GOLDEN SMART HOME TECHNOLOGY CORP. 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.