NATURAL ELIXIRS SDN BHD
⚠️ Moderate Risk
FEI: 3014376401 • Pelabuhan Klang • MALAYSIA
FEI Number
3014376401
Location
Pelabuhan Klang
Country
MALAYSIAAddress
No 17 Jalan Selat Selat, , Pelabuhan Klang, , 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).
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/1/2018 | 54FCR24SENNA (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/7/2018 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 7/31/2018 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is NATURAL ELIXIRS SDN BHD's FDA import refusal history?
NATURAL ELIXIRS SDN BHD (FEI: 3014376401) has 3 FDA import refusal record(s) in our database, spanning from 7/31/2018 to 10/1/2018.
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. NATURAL ELIXIRS SDN BHD's FEI number is 3014376401.
What types of violations has NATURAL ELIXIRS SDN BHD received?
NATURAL ELIXIRS 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 NATURAL ELIXIRS SDN BHD come from?
All FDA import refusal data for NATURAL ELIXIRS 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.