Koeleman India Pvt Ltd
⚠️ High Risk
FEI: 3004380049 • Bangalore • INDIA
FEI Number
3004380049
Location
Bangalore
Country
INDIAAddress
526 7th Cross, 4th Block Koramangala, , Bangalore, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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 |
|---|---|---|---|
| 11/8/2016 | 24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI20CUCUMBERS (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) | |
| 11/8/2016 | 24FCI50TOMATOES (FRUIT USED AS VEGETABLE) | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Koeleman India Pvt Ltd's FDA import refusal history?
Koeleman India Pvt Ltd (FEI: 3004380049) has 17 FDA import refusal record(s) in our database, spanning from 11/8/2016 to 11/8/2016.
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. Koeleman India Pvt Ltd's FEI number is 3004380049.
What types of violations has Koeleman India Pvt Ltd received?
Koeleman India Pvt Ltd 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 Koeleman India Pvt Ltd come from?
All FDA import refusal data for Koeleman India Pvt Ltd 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.