TECAN CDMO SOLUTIONS PN SDN BHD
⚠️ High Risk
FEI: 3039181934 • Simpang Ampat Simpang • MALAYSIA
FEI Number
3039181934
Location
Simpang Ampat Simpang
Country
MALAYSIAAddress
Lrg Perindust.Bukit Min, Simpang Ampat, Simpang Ampat Simpang, , 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is TECAN CDMO SOLUTIONS PN SDN BHD's FDA import refusal history?
TECAN CDMO SOLUTIONS PN SDN BHD (FEI: 3039181934) has 2 FDA import refusal record(s) in our database, spanning from 10/27/2025 to 10/27/2025.
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. TECAN CDMO SOLUTIONS PN SDN BHD's FEI number is 3039181934.
What types of violations has TECAN CDMO SOLUTIONS PN SDN BHD received?
TECAN CDMO SOLUTIONS PN 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 TECAN CDMO SOLUTIONS PN SDN BHD come from?
All FDA import refusal data for TECAN CDMO SOLUTIONS PN 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.