Karexx International Inc
⚠️ Moderate Risk
FEI: 1000608997 • Caloocan City, National Capital Region • PHILIPPINES
FEI Number
1000608997
Location
Caloocan City, National Capital Region
Country
PHILIPPINESAddress
No 2 Private Compound, , Caloocan City, National Capital Region, Philippines
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
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.
SULFITELBL
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/13/2003 | 23FCE17MACAPUNO (COCONUT SPORT), TOPPING | Los Angeles District Office (LOS-DO) | |
| 2/13/2003 | 21CCE01FRUIT COCKTAIL, MIXED FRUIT, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/13/2003 | 21UCE24PALM NUT (PALM FRUIT, SUGAR PALM), JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 2/13/2003 | 21UCE24PALM NUT (PALM FRUIT, SUGAR PALM), JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Karexx International Inc's FDA import refusal history?
Karexx International Inc (FEI: 1000608997) has 4 FDA import refusal record(s) in our database, spanning from 2/13/2003 to 2/13/2003.
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. Karexx International Inc's FEI number is 1000608997.
What types of violations has Karexx International Inc received?
Karexx International Inc has been cited for 2 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 Karexx International Inc come from?
All FDA import refusal data for Karexx International Inc 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.