LJack (M) SDN. BHD
⚠️ Moderate Risk
FEI: 3003579569 • Semenyih, Selangor • MALAYSIA
FEI Number
3003579569
Location
Semenyih, Selangor
Country
MALAYSIAAddress
Taman Industrial Mega, No 7 Jalan Mega a, Semenyih, Selangor, 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
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/16/2017 | 54YBZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 320LACKS FIRM | Division of Southeast Imports (DSEI) |
| 3/16/2017 | 54YBZ99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 320LACKS FIRM | Division of Southeast Imports (DSEI) |
| 1/28/2015 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/16/2004 | 66VCR99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is LJack (M) SDN. BHD's FDA import refusal history?
LJack (M) SDN. BHD (FEI: 3003579569) has 4 FDA import refusal record(s) in our database, spanning from 9/16/2004 to 3/16/2017.
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. LJack (M) SDN. BHD's FEI number is 3003579569.
What types of violations has LJack (M) SDN. BHD received?
LJack (M) SDN. BHD has been cited for 3 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 LJack (M) SDN. BHD come from?
All FDA import refusal data for LJack (M) 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.