MAXSILIN PRODUCTS SDN BHD
✅ Low Risk
FEI: 3014286516 • Shah Alam, Selangor • MALAYSIA
FEI Number
3014286516
Location
Shah Alam, Selangor
Country
MALAYSIAAddress
No 4-2-1 Jalan Setia Prima L U13/L Setia Alam, , Shah Alam, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 MAXSILIN PRODUCTS SDN BHD's FDA import refusal history?
MAXSILIN PRODUCTS SDN BHD (FEI: 3014286516) has 1 FDA import refusal record(s) in our database, spanning from 4/18/2018 to 4/18/2018.
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. MAXSILIN PRODUCTS SDN BHD's FEI number is 3014286516.
What types of violations has MAXSILIN PRODUCTS SDN BHD received?
MAXSILIN PRODUCTS SDN BHD 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 MAXSILIN PRODUCTS SDN BHD come from?
All FDA import refusal data for MAXSILIN PRODUCTS SDN BHD 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.