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
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/22/2026 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/22/2026 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southeast Imports (DSEI) |
| 1/22/2026 | 95REULASER AIMING PRODUCT, VISIBLE, SURVEYING, LEVELING, ALIGNMENT LASER PRODUCTS | 47NON STD | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Southeast Imports (DSEI) |
| 10/27/2025 | 95RDWGENERAL PURPOSE LASER PRODUCTS, NON-MEDICAL | 476NO REGISTR | Division of Southeast Imports (DSEI) |
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 5 FDA import refusal record(s) in our database, spanning from 10/27/2025 to 1/22/2026.
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 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 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.