Belgimex Taiwan Co Ltd
⚠️ Moderate Risk
FEI: 3003964370 • Taipei • TAIWAN
FEI Number
3003964370
Location
Taipei
Country
TAIWANAddress
Min Chuan E Rd 13fl, , 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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
Refusal History
Frequently Asked Questions
What is Belgimex Taiwan Co Ltd's FDA import refusal history?
Belgimex Taiwan Co Ltd (FEI: 3003964370) has 1 FDA import refusal record(s) in our database, spanning from 8/14/2003 to 8/14/2003.
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. Belgimex Taiwan Co Ltd's FEI number is 3003964370.
What types of violations has Belgimex Taiwan Co Ltd received?
Belgimex Taiwan Co Ltd 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 Belgimex Taiwan Co Ltd come from?
All FDA import refusal data for Belgimex Taiwan 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.