Kyvas International Co. (British Virgin Island)
⚠️ Moderate Risk
FEI: 3004074928 • Taipei • TAIWAN
FEI Number
3004074928
Location
Taipei
Country
TAIWANAddress
C/O:4th Fl. No. 475, Sec 2 Tidingkakau, , Taipei, , 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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/16/2012 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 508NO 510(K) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Kyvas International Co. (British Virgin Island)'s FDA import refusal history?
Kyvas International Co. (British Virgin Island) (FEI: 3004074928) has 1 FDA import refusal record(s) in our database, spanning from 8/16/2012 to 8/16/2012.
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. Kyvas International Co. (British Virgin Island)'s FEI number is 3004074928.
What types of violations has Kyvas International Co. (British Virgin Island) received?
Kyvas International Co. (British Virgin Island) 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 Kyvas International Co. (British Virgin Island) come from?
All FDA import refusal data for Kyvas International Co. (British Virgin Island) 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.