Karex Industries Sdn Bhd
⚠️ Moderate Risk
FEI: 1000535235 • Pontian, Johor • MALAYSIA
FEI Number
1000535235
Location
Pontian, Johor
Country
MALAYSIAAddress
Ptd 7906 & 7907, Taman Pontian Jaya, Batu 34, Pontian, 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
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).
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.
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.
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2023 | 85HISCONDOM | Division of Southeast Imports (DSEI) | |
| 4/23/2015 | 85HISCONDOM | New Orleans District Office (NOL-DO) | |
| 1/6/2014 | 54JYY08ALOE (HERBAL AND BOTANICAL TEAS II, (CONTINUED)) | Los Angeles District Office (LOS-DO) | |
| 2/23/2011 | 85HISCONDOM | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/15/2010 | 85HISCONDOM | 477HOLES | New York District Office (NYK-DO) |
| 8/11/2005 | 85HISCONDOM | Cincinnati District Office (CIN-DO) | |
| 7/22/2004 | 85HISCONDOM | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Karex Industries Sdn Bhd's FDA import refusal history?
Karex Industries Sdn Bhd (FEI: 1000535235) has 7 FDA import refusal record(s) in our database, spanning from 7/22/2004 to 12/15/2023.
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. Karex Industries Sdn Bhd's FEI number is 1000535235.
What types of violations has Karex Industries Sdn Bhd received?
Karex Industries 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 Karex Industries Sdn Bhd come from?
All FDA import refusal data for Karex Industries 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.