IKARL GLOBAL SDN. BHD.
⚠️ Moderate Risk
FEI: 3017887954 • Kuala Lumpur, WP Kuala Lumpur • MALAYSIA
FEI Number
3017887954
Location
Kuala Lumpur, WP Kuala Lumpur
Country
MALAYSIAAddress
No. 1 Jalan Shamelin Niaga 1, , Kuala Lumpur, WP Kuala Lumpur, Malaysia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is IKARL GLOBAL SDN. BHD.'s FDA import refusal history?
IKARL GLOBAL SDN. BHD. (FEI: 3017887954) has 1 FDA import refusal record(s) in our database, spanning from 8/18/2021 to 8/18/2021.
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. IKARL GLOBAL SDN. BHD.'s FEI number is 3017887954.
What types of violations has IKARL GLOBAL SDN. BHD. received?
IKARL GLOBAL SDN. BHD. has been cited for 4 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 IKARL GLOBAL SDN. BHD. come from?
All FDA import refusal data for IKARL GLOBAL 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.