Hsieh Wise Co., Ltd
⚠️ Moderate Risk
FEI: 3006648730 • Changhua • TAIWAN
FEI Number
3006648730
Location
Changhua
Country
TAIWANAddress
If 17 Lane 95 Sec. 3, , Changhua, , 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
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).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/10/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 8/10/2011 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/21/2011 | 79GDTSTAPLE, REMOVABLE (SKIN) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 6/21/2011 | 79GDTSTAPLE, REMOVABLE (SKIN) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/26/2011 | 76EFLFORCEPS, DRESSING, DENTAL | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 5/26/2011 | 79HRQHEMOSTAT | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 12/13/2010 | 79LRPTRAY, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 11/4/2010 | 79LRPTRAY, SURGICAL | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 7/30/2010 | 79FZTCUTTER, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
| 7/7/2010 | 79FZTCUTTER, SURGICAL | 290DE IMP GMP | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Hsieh Wise Co., Ltd's FDA import refusal history?
Hsieh Wise Co., Ltd (FEI: 3006648730) has 10 FDA import refusal record(s) in our database, spanning from 7/7/2010 to 8/10/2011.
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. Hsieh Wise Co., Ltd's FEI number is 3006648730.
What types of violations has Hsieh Wise Co., Ltd received?
Hsieh Wise Co., Ltd has been cited for 3 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 Hsieh Wise Co., Ltd come from?
All FDA import refusal data for Hsieh Wise Co., 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.