TaiDoc Technology Corporation
⚠️ Moderate Risk
FEI: 3004145393 • New Taipei City • TAIWAN
FEI Number
3004145393
Location
New Taipei City
Country
TAIWANAddress
Wugu District, B1-7f, No.127, Wugong 2nd Rd., New Taipei 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
3904
3905
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/10/2025 | 75JINNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.) | Division of Southeast Imports (DSEI) | |
| 10/22/2025 | 75CHHENZYMATIC ESTERASE--OXIDASE, CHOLESTEROL | Division of Southeast Imports (DSEI) | |
| 10/22/2025 | 75CGAGLUCOSE OXIDASE, GLUCOSE | Division of Southeast Imports (DSEI) | |
| 10/22/2025 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | Division of Southeast Imports (DSEI) | |
| 6/17/2025 | 80FLLTHERMOMETER, ELECTRONIC, CLINICAL | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/10/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 2/16/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of West Coast Imports (DWCI) |
| 12/11/2020 | 83OTTRESEARCH USE ONLY/MICROBIOLOGY | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 5/14/2007 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | 336INCONSPICU | New York District Office (NYK-DO) |
Frequently Asked Questions
What is TaiDoc Technology Corporation's FDA import refusal history?
TaiDoc Technology Corporation (FEI: 3004145393) has 9 FDA import refusal record(s) in our database, spanning from 5/14/2007 to 11/10/2025.
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. TaiDoc Technology Corporation's FEI number is 3004145393.
What types of violations has TaiDoc Technology Corporation received?
TaiDoc Technology Corporation has been cited for 7 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 TaiDoc Technology Corporation come from?
All FDA import refusal data for TaiDoc Technology 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.