EXPO CONNECT SDN BHD
⚠️ Moderate Risk
FEI: 3015233557 • Seri Kembangan, Selangor • MALAYSIA
FEI Number
3015233557
Location
Seri Kembangan, Selangor
Country
MALAYSIAAddress
Street Mall One South, , Seri Kembangan, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
708UDECAPI
The article has been determined to contain an API that is undeclared on the label or accompanying labeling.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/1/2021 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/24/2021 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2021 | 54YYY10ROYAL JELLY (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2020 | 54YYY10ROYAL JELLY (VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/21/2019 | 66SCY51TADALAFIL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EXPO CONNECT SDN BHD's FDA import refusal history?
EXPO CONNECT SDN BHD (FEI: 3015233557) has 5 FDA import refusal record(s) in our database, spanning from 5/21/2019 to 9/1/2021.
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. EXPO CONNECT SDN BHD's FEI number is 3015233557.
What types of violations has EXPO CONNECT SDN BHD received?
EXPO CONNECT SDN BHD has been cited for 4 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 EXPO CONNECT SDN BHD come from?
All FDA import refusal data for EXPO CONNECT 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.