E-Care Technology Corp.
⚠️ Moderate Risk
FEI: 3007557677 • Chubei City, Hsinchu District • TAIWAN
FEI Number
3007557677
Location
Chubei City, Hsinchu District
Country
TAIWANAddress
8f-11, No. 35 Hsin-Tai Rd., Chubei City, Hsinchu District, 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
DEVGMPS
The article appears to be a device for which the methods, facilities, or controls used in, or the facilities or controls used for, its manufacture, packing, storage or installation do not conform to the requirements of Sec. 520(f) and any applicable variance under Sec. 520(f)(2).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/24/2020 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 7/1/2020 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 2780DEVICEGMPS | Division of West Coast Imports (DWCI) |
| 2/8/2016 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 3724DEVGMPS | New York District Office (NYK-DO) |
| 2/4/2016 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 3724DEVGMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is E-Care Technology Corp.'s FDA import refusal history?
E-Care Technology Corp. (FEI: 3007557677) has 4 FDA import refusal record(s) in our database, spanning from 2/4/2016 to 8/24/2020.
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. E-Care Technology Corp.'s FEI number is 3007557677.
What types of violations has E-Care Technology Corp. received?
E-Care Technology Corp. 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 E-Care Technology Corp. come from?
All FDA import refusal data for E-Care 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.