Medcare Smart SDN BHD
⚠️ Moderate Risk
FEI: 3012190868 • Kuala, Lampur • MALAYSIA
FEI Number
3012190868
Location
Kuala, Lampur
Country
MALAYSIAAddress
21-1 Jalan kg Pandan, Taman Maluri 55100, Kuala, Lampur, 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
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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/6/2022 | 36CYW04HONEY | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/17/2021 | 66SCY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2018 | 54YCL10ROYAL JELLY (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | Division of Southeast Imports (DSEI) | |
| 4/5/2016 | 36CYY04HONEY | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Medcare Smart SDN BHD's FDA import refusal history?
Medcare Smart SDN BHD (FEI: 3012190868) has 4 FDA import refusal record(s) in our database, spanning from 4/5/2016 to 5/6/2022.
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. Medcare Smart SDN BHD's FEI number is 3012190868.
What types of violations has Medcare Smart SDN BHD received?
Medcare Smart SDN BHD has been cited for 6 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 Medcare Smart SDN BHD come from?
All FDA import refusal data for Medcare Smart 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.