BORRION ENT CO LTD
✅ Low Risk
FEI: 3013189524 • Tainan • TAIWAN
FEI Number
3013189524
Location
Tainan
Country
TAIWANAddress
205, 1 F, NO 24 Lane; Chung, Tainan, , 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
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
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
Frequently Asked Questions
What is BORRION ENT CO LTD's FDA import refusal history?
BORRION ENT CO LTD (FEI: 3013189524) has 1 FDA import refusal record(s) in our database, spanning from 3/22/2017 to 3/22/2017.
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. BORRION ENT CO LTD's FEI number is 3013189524.
What types of violations has BORRION ENT CO LTD received?
BORRION ENT 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 BORRION ENT CO LTD come from?
All FDA import refusal data for BORRION ENT 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.