Rolence Ent. Inc.
⚠️ Moderate Risk
FEI: 3002772487 • Chungli, Taoyuan • TAIWAN
FEI Number
3002772487
Location
Chungli, Taoyuan
Country
TAIWANAddress
No. 18-3, Lane 231 Pu Chung Road, , Chungli, Taoyuan, 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).
Refusal History
Frequently Asked Questions
What is Rolence Ent. Inc.'s FDA import refusal history?
Rolence Ent. Inc. (FEI: 3002772487) has 2 FDA import refusal record(s) in our database, spanning from 12/7/2006 to 7/26/2010.
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. Rolence Ent. Inc.'s FEI number is 3002772487.
What types of violations has Rolence Ent. Inc. received?
Rolence Ent. Inc. 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 Rolence Ent. Inc. come from?
All FDA import refusal data for Rolence Ent. Inc. 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.