DXN Industries (M) Sdn. Bhd.
⚠️ Moderate Risk
FEI: 3006563455 • Jitra, Kedah • MALAYSIA
FEI Number
3006563455
Location
Jitra, Kedah
Country
MALAYSIAAddress
Kg. Padang Panjang, Jalan Bukit Wang, Jitra, Kedah, 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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/10/2020 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Division of West Coast Imports (DWCI) |
| 3/10/2020 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Division of West Coast Imports (DWCI) |
| 3/10/2020 | 53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES) | 197COSM COLOR | Division of West Coast Imports (DWCI) |
| 9/23/2013 | 65LBJ11TITANIUM DIOXIDE (PROTECTANT) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is DXN Industries (M) Sdn. Bhd.'s FDA import refusal history?
DXN Industries (M) Sdn. Bhd. (FEI: 3006563455) has 4 FDA import refusal record(s) in our database, spanning from 9/23/2013 to 3/10/2020.
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. DXN Industries (M) Sdn. Bhd.'s FEI number is 3006563455.
What types of violations has DXN Industries (M) Sdn. Bhd. received?
DXN Industries (M) 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 DXN Industries (M) Sdn. Bhd. come from?
All FDA import refusal data for DXN Industries (M) 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.