Mellips SDN BHD
⚠️ Moderate Risk
FEI: 3010022442 • Melaka, Melaka • MALAYSIA
FEI Number
3010022442
Location
Melaka, Melaka
Country
MALAYSIAAddress
Lot 28, Jalan Tun, Melaka, Melaka, 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.
Refusal History
Frequently Asked Questions
What is Mellips SDN BHD's FDA import refusal history?
Mellips SDN BHD (FEI: 3010022442) has 2 FDA import refusal record(s) in our database, spanning from 3/8/2013 to 10/22/2013.
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. Mellips SDN BHD's FEI number is 3010022442.
What types of violations has Mellips SDN BHD received?
Mellips SDN BHD has been cited for 2 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 Mellips SDN BHD come from?
All FDA import refusal data for Mellips 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.