Chewink Corp
✅ Low Risk
FEI: 3009241130 • New Taipei • TAIWAN
FEI Number
3009241130
Location
New Taipei
Country
TAIWANAddress
10 Zhongzheng Road, , New Taipei, , Taiwan
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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 |
|---|---|---|---|
| 4/26/2012 | 76EFWTOOTHBRUSH, MANUAL | 341REGISTERED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Chewink Corp's FDA import refusal history?
Chewink Corp (FEI: 3009241130) has 1 FDA import refusal record(s) in our database, spanning from 4/26/2012 to 4/26/2012.
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. Chewink Corp's FEI number is 3009241130.
What types of violations has Chewink Corp received?
Chewink Corp 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 Chewink Corp come from?
All FDA import refusal data for Chewink Corp 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.