LS Rubber Sdn. Bhd.
⚠️ Moderate Risk
FEI: 3002807508 • Senai, Johor • MALAYSIA
FEI Number
3002807508
Location
Senai, Johor
Country
MALAYSIAAddress
Plo 22 (Phase 1), Jalan Perindustrian Senai 3, Senai, Johor, 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.
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).
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2005 | 85HISCONDOM | 477HOLES | New Orleans District Office (NOL-DO) |
| 7/20/2005 | 78LSTDEVICE, ERECTILE DYSFUNCTION | San Francisco District Office (SAN-DO) | |
| 6/29/2005 | 85HISCONDOM | 477HOLES | Division of Southeast Imports (DSEI) |
| 11/10/2004 | 85HISCONDOM | San Francisco District Office (SAN-DO) | |
| 10/23/2004 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 3/19/2004 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 3/17/2004 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 1/14/2004 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 1/14/2004 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 12/4/2003 | 85HISCONDOM | 477HOLES | Baltimore District Office (BLT-DO) |
| 9/5/2003 | 85HISCONDOM | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is LS Rubber Sdn. Bhd.'s FDA import refusal history?
LS Rubber Sdn. Bhd. (FEI: 3002807508) has 11 FDA import refusal record(s) in our database, spanning from 9/5/2003 to 9/26/2005.
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. LS Rubber Sdn. Bhd.'s FEI number is 3002807508.
What types of violations has LS Rubber Sdn. Bhd. received?
LS Rubber Sdn. Bhd. has been cited for 6 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 LS Rubber Sdn. Bhd. come from?
All FDA import refusal data for LS Rubber 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.