KINGDOM ETUMAX BIO SDN BHD
⚠️ High Risk
FEI: 3026093959 • Petaling, Selangor • MALAYSIA
FEI Number
3026093959
Location
Petaling, Selangor
Country
MALAYSIAAddress
Seksy, 102 Jalan Gasing, Petaling, Selangor, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/5/2025 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/6/2023 | 66SCY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/5/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 4/5/2023 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is KINGDOM ETUMAX BIO SDN BHD's FDA import refusal history?
KINGDOM ETUMAX BIO SDN BHD (FEI: 3026093959) has 4 FDA import refusal record(s) in our database, spanning from 4/5/2023 to 5/5/2025.
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. KINGDOM ETUMAX BIO SDN BHD's FEI number is 3026093959.
What types of violations has KINGDOM ETUMAX BIO SDN BHD received?
KINGDOM ETUMAX BIO 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 KINGDOM ETUMAX BIO SDN BHD come from?
All FDA import refusal data for KINGDOM ETUMAX BIO 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.