SM Biomed Sdn Bhd
⚠️ High Risk
FEI: 3005983287 • Sungai Petani, Kedah • MALAYSIA
FEI Number
3005983287
Location
Sungai Petani, Kedah
Country
MALAYSIAAddress
Lot 90, Sungai Petani, , Sungai Petani, Kedah, Malaysia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is SM Biomed Sdn Bhd's FDA import refusal history?
SM Biomed Sdn Bhd (FEI: 3005983287) has 2 FDA import refusal record(s) in our database, spanning from 11/25/2014 to 3/14/2025.
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. SM Biomed Sdn Bhd's FEI number is 3005983287.
What types of violations has SM Biomed Sdn Bhd received?
SM Biomed Sdn Bhd 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 SM Biomed Sdn Bhd come from?
All FDA import refusal data for SM Biomed 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.