Ever Polymer Co.,Ltd.
⚠️ Moderate Risk
FEI: 3004459521 • Taoyuan City • TAIWAN
FEI Number
3004459521
Location
Taoyuan City
Country
TAIWANAddress
No 538 Minsheng N. Rd., Sec. 1, Guishan Dist., Taoyuan 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 Ever Polymer Co.,Ltd.'s FDA import refusal history?
Ever Polymer Co.,Ltd. (FEI: 3004459521) has 3 FDA import refusal record(s) in our database, spanning from 10/29/2004 to 11/5/2004.
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. Ever Polymer Co.,Ltd.'s FEI number is 3004459521.
What types of violations has Ever Polymer Co.,Ltd. received?
Ever Polymer Co.,Ltd. has been cited for 3 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 Ever Polymer Co.,Ltd. come from?
All FDA import refusal data for Ever Polymer 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.