Kossan Latex Industries (M) Sdn Bhd
⚠️ Moderate Risk
FEI: 3005632797 • Klang, Selangor • MALAYSIA
FEI Number
3005632797
Location
Klang, Selangor
Country
MALAYSIAAddress
Lot 6129, 5 1/4 Miles Jalan Haji Abdul Manan, Jalan Meru, Klang, 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/24/2017 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Southeast Imports (DSEI) | |
| 2/24/2017 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | Division of Southeast Imports (DSEI) | |
| 9/14/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 9/14/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 9/14/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 8/6/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Chicago District Office (CHI-DO) |
| 6/19/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
| 6/15/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 6/15/2009 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New York District Office (NYK-DO) |
| 3/19/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
| 3/19/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
| 3/19/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
| 3/19/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
| 3/19/2009 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | New York District Office (NYK-DO) |
| 12/11/2008 | 80LZAGLOVE, PATIENT EXAMINATION, POLY | 477HOLES | Minneapolis District Office (MIN-DO) |
| 5/23/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 5/11/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 4/10/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Los Angeles District Office (LOS-DO) |
| 4/10/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 4/10/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 4/10/2007 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | Atlanta District Office (ATL-DO) |
| 4/23/2002 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 479DV QUALITY | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Kossan Latex Industries (M) Sdn Bhd's FDA import refusal history?
Kossan Latex Industries (M) Sdn Bhd (FEI: 3005632797) has 22 FDA import refusal record(s) in our database, spanning from 4/23/2002 to 2/24/2017.
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. Kossan Latex Industries (M) Sdn Bhd's FEI number is 3005632797.
What types of violations has Kossan Latex Industries (M) Sdn Bhd received?
Kossan Latex Industries (M) 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 Kossan Latex Industries (M) Sdn Bhd come from?
All FDA import refusal data for Kossan Latex 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.