Latexx Manufacturing Sdn Bhd
⚠️ Moderate Risk
FEI: 3009157666 • Taiping, Perak • MALAYSIA
FEI Number
3009157666
Location
Taiping, Perak
Country
MALAYSIAAddress
Lot 18374, Kamunting Industrial Estate, Jalan Perusahaan 3, Taiping, Perak, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/12/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Northeast Imports (DNEI) |
| 1/29/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 1/9/2024 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of Southwest Imports (DSWI) |
| 11/16/2023 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Latexx Manufacturing Sdn Bhd's FDA import refusal history?
Latexx Manufacturing Sdn Bhd (FEI: 3009157666) has 4 FDA import refusal record(s) in our database, spanning from 11/16/2023 to 2/12/2024.
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. Latexx Manufacturing Sdn Bhd's FEI number is 3009157666.
What types of violations has Latexx Manufacturing Sdn Bhd received?
Latexx Manufacturing Sdn Bhd has been cited for 1 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 Latexx Manufacturing Sdn Bhd come from?
All FDA import refusal data for Latexx Manufacturing 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.