Taiwan Stanch Co Ltd
⚠️ Moderate Risk
FEI: 1000547756 • Taipei City • TAIWAN
FEI Number
1000547756
Location
Taipei City
Country
TAIWANAddress
2nd Fl., Zhongshan Dist., 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
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 |
|---|---|---|---|
| 10/31/2007 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/31/2007 | 89IMDPACK, HOT OR COLD, DISPOSABLE | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/31/2007 | 80KYSINSOLES, MEDICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/31/2007 | 80IKYMATTRESS, FLOTATION THERAPY, NON-POWERED | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/31/2007 | 78FCEKIT, ENEMA, (FOR CLEANING PURPOSE) | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/31/2007 | 80KYRBAG, ICE | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/31/2007 | 85HEDDOUCHE APPARATUS, VAGINAL, THERAPEUTIC | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Taiwan Stanch Co Ltd's FDA import refusal history?
Taiwan Stanch Co Ltd (FEI: 1000547756) has 7 FDA import refusal record(s) in our database, spanning from 10/31/2007 to 10/31/2007.
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. Taiwan Stanch Co Ltd's FEI number is 1000547756.
What types of violations has Taiwan Stanch Co Ltd received?
Taiwan Stanch Co 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 Taiwan Stanch Co Ltd come from?
All FDA import refusal data for Taiwan Stanch 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.