Wandy Rubber Industrial Co
⚠️ Moderate Risk
FEI: 3004125196 • Taipei • TAIWAN
FEI Number
3004125196
Location
Taipei
Country
TAIWANAddress
No 24 Alley37 Lane 392 Ist Rd, , 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
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).
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
Frequently Asked Questions
What is Wandy Rubber Industrial Co's FDA import refusal history?
Wandy Rubber Industrial Co (FEI: 3004125196) has 2 FDA import refusal record(s) in our database, spanning from 12/11/2009 to 12/11/2009.
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. Wandy Rubber Industrial Co's FEI number is 3004125196.
What types of violations has Wandy Rubber Industrial Co received?
Wandy Rubber Industrial Co 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 Wandy Rubber Industrial Co come from?
All FDA import refusal data for Wandy Rubber Industrial Co 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.