Max Legend Enterprises
✅ Low Risk
FEI: 3003586123 • Subang Jaya, Selangor • MALAYSIA
FEI Number
3003586123
Location
Subang Jaya, Selangor
Country
MALAYSIAAddress
Taman Perindusrian, 8 Jalan Tp 2, Subang Jaya, Selangor, Malaysia
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
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 Max Legend Enterprises's FDA import refusal history?
Max Legend Enterprises (FEI: 3003586123) has 2 FDA import refusal record(s) in our database, spanning from 11/2/2005 to 11/2/2005.
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. Max Legend Enterprises's FEI number is 3003586123.
What types of violations has Max Legend Enterprises received?
Max Legend Enterprises 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 Max Legend Enterprises come from?
All FDA import refusal data for Max Legend Enterprises 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.