Ken Dall Enterprise Co., Ltd.
⚠️ Moderate Risk
FEI: 1000431265 • New Taipei City • TAIWAN
FEI Number
1000431265
Location
New Taipei City
Country
TAIWANAddress
Alley 22, Lane 49,, 6 Tungfeng St.; Shulin Dist., 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
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is Ken Dall Enterprise Co., Ltd.'s FDA import refusal history?
Ken Dall Enterprise Co., Ltd. (FEI: 1000431265) has 1 FDA import refusal record(s) in our database, spanning from 9/23/2014 to 9/23/2014.
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. Ken Dall Enterprise Co., Ltd.'s FEI number is 1000431265.
What types of violations has Ken Dall Enterprise Co., Ltd. received?
Ken Dall Enterprise Co., Ltd. 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 Ken Dall Enterprise Co., Ltd. come from?
All FDA import refusal data for Ken Dall Enterprise 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.