Medcare Smart SDN BHD
FDA import alert and refusal historyKuala, MalaysiaFEI 3012190868
As of October 26, 2026, Medcare Smart SDN BHD (Kuala, Malaysia) is on the red list of FDA Import Alert 54-16 (Foods/supplements with active pharmaceutical ingredient) for golden royal honey, published by FDA on September 22, 2016, and has 2 FDA import refusals recorded since October 2016.
Data from FDA public records, last checked . Request a correction
Current status
- Import alerts
- IA 54-16 · red list
- Last import refusal
- Honey · UNAPPROVED
- Last warning letter
- None found
- Last inspection
- None on record
Every FDA record for Medcare Smart SDN BHD
3 records, newest first. Each line links to the FDA page it came from.
2022
- Import refusalRefused, HoneyUNAPPROVEDEntry 799-8232942-6Source
2018
- Import refusalRefused, Royal jelly (vit/min/protein/unconventional dietary spec for human/animal, n.e.c.)DIETARYLBLNCONTACTLABELINGNUTRIT LBLHEALTH CUNAPPROVEDEntry SCS-2579946-2Source
2016
- Import alert listingListed on Import Alert 54-16red listGolden Royal HoneySource
Refusal charges, in plain English
- UNAPPROVED2 refused lines
Unapproved new drug
The product appeared to be a new drug within the meaning of section 201(p) of the FD&C Act without an approved New Drug Application. FDA can apply this charge to a food or supplement whose labeling presents it for drug uses.
- DIETARYLBL1 refused line
Not identified as a dietary supplement
The label appeared not to identify the product with the term "dietary supplement" (which may be modified with the name of an ingredient).
- HEALTH C1 refused line
Unauthorized nutrient content or health claim
The label or labeling appeared to carry a nutrient content claim or health claim that is not authorized.
- LABELING1 refused line
Fair Packaging and Labeling Act
The package appeared not to meet the Fair Packaging and Labeling Act because of the placement, form, or contents of a required label statement.
- NCONTACT1 refused line
No U.S. adverse event contact on supplement label
The dietary supplement label appeared not to show a U.S. address or phone number through which a serious adverse event can be reported.
- NUTRIT LBL1 refused line
Nutrition information missing from label
The label or labeling appeared not to carry the nutrition information that U.S. law requires for the food.
Questions about Medcare Smart SDN BHD
- Is Medcare Smart SDN BHD on an FDA import alert?
- Yes. As of October 26, 2026, Medcare Smart SDN BHD is on the red list of FDA Import Alert 54-16, “Foods/supplements with active pharmaceutical ingredient”, for golden royal honey; FDA published the listing on September 22, 2016.
- Has FDA refused shipments from Medcare Smart SDN BHD?
- Yes. FDA refused 2 shipment lines from Medcare Smart SDN BHD between December 19, 2018 and May 6, 2022. The most recent, on May 6, 2022, was honey, charged as UNAPPROVED (unapproved new drug).
- Why did FDA refuse Medcare Smart SDN BHD's shipments?
- The most frequent charges are UNAPPROVED (unapproved new drug, 2 lines) and DIETARYLBL (not identified as a dietary supplement, 1 line).
- What is Medcare Smart SDN BHD's FEI number?
- Medcare Smart SDN BHD's FDA Establishment Identifier (FEI) is 3012190868.
- Can shipments from Medcare Smart SDN BHD still enter the U.S.?
- Shipments of golden royal honey from Medcare Smart SDN BHD can be detained without physical examination under Import Alert 54-16; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).
Buying from Medcare Smart SDN BHD?
Watch it and get the FDA record the day it changes. Free for one supplier.
SupplierRadar is not affiliated with the U.S. Food and Drug Administration. Data comes from public FDA records and may contain errors. This is not legal advice; importers remain responsible for their supplier evaluations.