Innolatex Sdn. Bhd.
⚠️ Moderate Risk
FEI: 3003117682 • Port Klang, Selangor • MALAYSIA
FEI Number
3003117682
Location
Port Klang, Selangor
Country
MALAYSIAAddress
Lot 591 & 594, Pandamaran Industrial Estate, Persiaran Raja Lumu, Port 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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 |
|---|---|---|---|
| 3/12/2012 | 85OBUFEMALE CONDOM, REPEATED USE | Los Angeles District Office (LOS-DO) | |
| 3/12/2012 | 85OBUFEMALE CONDOM, REPEATED USE | Los Angeles District Office (LOS-DO) | |
| 3/12/2012 | 85OBUFEMALE CONDOM, REPEATED USE | Los Angeles District Office (LOS-DO) | |
| 3/12/2012 | 85OBUFEMALE CONDOM, REPEATED USE | Los Angeles District Office (LOS-DO) | |
| 11/16/2011 | 85HISCONDOM | 2780DEVICEGMPS | New Orleans District Office (NOL-DO) |
| 7/28/2011 | 85HISCONDOM | 2780DEVICEGMPS | Atlanta District Office (ATL-DO) |
| 7/28/2011 | 85HISCONDOM | 2780DEVICEGMPS | Atlanta District Office (ATL-DO) |
| 7/28/2011 | 85HISCONDOM | 2780DEVICEGMPS | Atlanta District Office (ATL-DO) |
| 7/28/2011 | 85HISCONDOM | 2780DEVICEGMPS | Atlanta District Office (ATL-DO) |
| 7/28/2011 | 85HISCONDOM | 2780DEVICEGMPS | Atlanta District Office (ATL-DO) |
| 7/28/2011 | 85HISCONDOM | 2780DEVICEGMPS | Atlanta District Office (ATL-DO) |
| 7/28/2011 | 85HISCONDOM | 2780DEVICEGMPS | Atlanta District Office (ATL-DO) |
| 7/28/2011 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/28/2011 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/28/2011 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 7/18/2007 | 85HISCONDOM | 477HOLES | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Innolatex Sdn. Bhd.'s FDA import refusal history?
Innolatex Sdn. Bhd. (FEI: 3003117682) has 16 FDA import refusal record(s) in our database, spanning from 7/18/2007 to 3/12/2012.
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. Innolatex Sdn. Bhd.'s FEI number is 3003117682.
What types of violations has Innolatex Sdn. Bhd. received?
Innolatex 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 Innolatex Sdn. Bhd. come from?
All FDA import refusal data for Innolatex 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.