Latexx Manufacturing Sdn Bhd
⚠️ High Risk
FEI: 3003256709 • Taiping Perak • MALAYSIA
FEI Number
3003256709
Location
Taiping Perak
Country
MALAYSIAAddress
Pt 5054, Jalan Perusahaan 3, Kamunting Industrial Estate, Taiping Perak, , Malaysia
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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 |
|---|---|---|---|
| 9/16/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | San Francisco District Office (SAN-DO) |
| 9/16/2011 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | San Francisco District Office (SAN-DO) |
| 9/16/2011 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | San Francisco District Office (SAN-DO) |
| 9/16/2011 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | San Francisco District Office (SAN-DO) |
| 9/16/2011 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | San Francisco District Office (SAN-DO) |
| 8/30/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 8/30/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 8/30/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 8/30/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 8/9/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 8/9/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 8/9/2011 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/12/2011 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | San Francisco District Office (SAN-DO) |
| 2/18/2011 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | San Francisco District Office (SAN-DO) |
| 2/16/2011 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | San Francisco District Office (SAN-DO) |
| 12/21/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 79KGOSURGEON'S GLOVES | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 79KGOSURGEON'S GLOVES | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 79KGOSURGEON'S GLOVES | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 1/28/2010 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Los Angeles District Office (LOS-DO) |
| 11/17/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 9/30/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 8/20/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 8/20/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 8/20/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 8/20/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 8/20/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 8/20/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 8/20/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 8/20/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | San Francisco District Office (SAN-DO) |
| 7/28/2009 | 80FMCGLOVE, PATIENT EXAMINATION | 477HOLES | New York District Office (NYK-DO) |
| 4/22/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Baltimore District Office (BLT-DO) |
| 8/17/2006 | 80NPCGLOVE, PATIENT EXAMINATION, POWDER FREE, | 477HOLES | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Latexx Manufacturing Sdn Bhd's FDA import refusal history?
Latexx Manufacturing Sdn Bhd (FEI: 3003256709) has 47 FDA import refusal record(s) in our database, spanning from 8/17/2006 to 9/16/2011.
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 3003256709.
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.